Cardiovascular device product codes

437 FDA product codes. All panels.

• BYS — Oxygenator, Long Term Support Greater Than 6 Hours (Class II, 3 clearances)
• CAC — Apparatus, Autotransfusion (Class II, 195 clearances)
• DPS — Electrocardiograph (Class II, 575 clearances)
• DPT — Probe, Blood-Flow, Extravascular (Class II, 48 clearances)
• DPW — Flowmeter, Blood, Cardiovascular (Class II, 137 clearances)
• DQB — Phlebograph, Impedance (Class II, 3 clearances)
• DQC — Phonocardiograph (Class I, 18 clearances)
• DQD — Stethoscope, Electronic (Class II, 153 clearances)
• DQE — Catheter, Oximeter, Fiber-Optic (Class II, 19 clearances)
• DQG — Microsphere, Trace (Class III)
• DQH — Cardiograph, Apex (Vibrocardiograph) (Class II, 1 clearances)
• DQK — Computer, Diagnostic, Programmable (Class II, 427 clearances)
• DQO — Catheter, Intravascular, Diagnostic (Class II, 499 clearances)
• DQP — Kit, Balloon Repair, Catheter (Class III)
• DQR — Cannula, Catheter (Class II, 25 clearances)
• DQT — Occluder, Catheter Tip (Class II, 12 clearances)
• DQX — Wire, Guide, Catheter (Class II, 763 clearances)
• DQY — Catheter, Percutaneous (Class II, 888 clearances)
• DRA — Catheter, Steerable (Class II, 41 clearances)
• DRB — Stylet, Catheter (Class II, 28 clearances)
• DRC — Trocar (Class II, 51 clearances)
• DRE — Dilator, Vessel, For Percutaneous Catheterization (Class II, 104 clearances)
• DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II, 185 clearances)
• DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II, 191 clearances)
• DRI — Monitor, Line Isolation (Class I, 4 clearances)
• DRJ — System, Signal Isolation (Class I, 4 clearances)
• DRK — Dc-Defibrillator, High Energy, (Including Paddles) (Class III, 1 clearances)
• DRL — Tester, Defibrillator (Class II, 19 clearances)
• DRM — Compressor, Cardiac, External (Class II, 45 clearances)
• DRN — Device, Counter-Pulsating, External (Class II, 34 clearances)
• DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) (Class II, 84 clearances)
• DRP — Tourniquet, Automatic Rotating (Class II)
• DRQ — Amplifier And Signal Conditioner, Transducer Signal (Class II, 27 clearances)
• DRR — Amplifier And Signal Conditioner, Biopotential (Class II, 24 clearances)
• DRS — Transducer, Blood-Pressure, Extravascular (Class II, 148 clearances)
• DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (Class II, 338 clearances)
• DRW — Adaptor, Lead Switching, Electrocardiograph (Class II, 8 clearances)
• DRX — Electrode, Electrocardiograph (Class II, 329 clearances)
• DRY — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass (Class II, 47 clearances)
• DRZ — Oscillometer (Class II)
• DSA — Cable, Transducer And Electrode, Patient, (Including Connector) (Class II, 105 clearances)
• DSB — Plethysmograph, Impedance (Class II, 114 clearances)
• DSF — Recorder, Paper Chart (Class I, 87 clearances)
• DSH — Recorder, Magnetic Tape, Medical (Class II, 194 clearances)
• DSI — Detector And Alarm, Arrhythmia (Class II, 398 clearances)
• DSJ — Alarm, Blood-Pressure (Class II, 6 clearances)
• DSK — Computer, Blood-Pressure (Class II, 77 clearances)
• DSM — Alarm, Leakage Current, Portable (Class I, 1 clearances)
• DSP — System, Balloon, Intra-Aortic And Control (Class II, 162 clearances)
• DSQ — Ventricular (Assist) Bypass (Class III)
• DSR — Stimulator, Carotid Sinus Nerve (Class III)
• DSS — Clip, Vascular (Class II, 8 clearances)
• DST — Clip, Vena-Cava (Class II, 1 clearances)
• DSW — Bag, Polymeric Mesh, Pacemaker (Class I)
• DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II, 188 clearances)
• DSZ — Pacemaker Battery (Class III)
• DTA — Tester, Pacemaker Electrode Function (Class II, 10 clearances)
• DTB — Permanent Pacemaker Electrode (Class III, 487 clearances)
• DTC — Analyzer, Pacemaker Generator Function (Class II, 30 clearances)
• DTD — Pacemaker Lead Adaptor (Class II, 103 clearances)
• DTE — Pulse-Generator, Pacemaker, External (Class II, 65 clearances)
• DTF — Tools, Pacemaker Service (Class I, 2 clearances)
• DTG — Magnet, Test, Pacemaker (Class I, 5 clearances)
• DTI — Sizer, Heart-Valve, Prosthesis (Class I, 7 clearances)
• DTJ — Holder, Heart-Valve, Prosthesis (Class I, 12 clearances)
• DTK — Filter, Intravascular, Cardiovascular (Class II, 83 clearances)
• DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II, 137 clearances)
• DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II, 96 clearances)
• DTN — Reservoir, Blood, Cardiopulmonary Bypass (Class II, 169 clearances)
• DTP — Defoamer, Cardiopulmonary Bypass (Class II, 34 clearances)
• DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass (Class II, 52 clearances)
• DTR — Heat-Exchanger, Cardiopulmonary Bypass (Class II, 91 clearances)
• DTS — Sucker, Cardiotomy Return, Cardiopulmonary Bypass (Class II, 9 clearances)
• DTW — Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass (Class II, 17 clearances)
• DTX — Gas Control Unit, Cardiopulmonary Bypass (Class II, 10 clearances)
• DTY — Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass (Class II, 8 clearances)
• DTZ — Oxygenator, Cardiopulmonary Bypass (Class II, 254 clearances)
• DWA — Control, Pump Speed, Cardiopulmonary Bypass (Class II, 37 clearances)
• DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type (Class II, 21 clearances)
• DWC — Controller, Temperature, Cardiopulmonary Bypass (Class II, 30 clearances)
• DWD — Suction Control, Intracardiac, Cardiopulmonary Bypass (Class II, 15 clearances)
• DWE — Tubing, Pump, Cardiopulmonary Bypass (Class II, 21 clearances)
• DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II, 401 clearances)
• DWJ — System, Thermal Regulating (Class II, 158 clearances)
• DWP — Dilator, Vessel, Surgical (Class II, 20 clearances)
• DWQ — Stripper, Vein, External (Class II, 8 clearances)
• DWS — Instruments, Surgical, Cardiovascular (Class I, 71 clearances)
• DWX — Stripper, Artery, Intraluminal (Class II, 14 clearances)
• DWZ — Device, Biopsy, Endomyocardial (Class II, 23 clearances)
• DXC — Clamp, Vascular (Class II, 202 clearances)
• DXE — Catheter, Embolectomy (Class II, 74 clearances)
• DXF — Catheter, Septostomy (Class II, 20 clearances)
• DXG — Computer, Diagnostic, Pre-Programmed, Single-Function (Class II, 177 clearances)
• DXH — Transmitters And Receivers, Electrocardiograph, Telephone (Class II, 297 clearances)
• DXJ — Display, Cathode-Ray Tube, Medical (Class II, 78 clearances)
• DXK — Echocardiograph (Class II, 78 clearances)
• DXL — Injector, Indicator (Class II, 3 clearances)
• DXM — Densitometer (Class II, 2 clearances)
• DXN — System, Measurement, Blood-Pressure, Non-Invasive (Class II, 1,211 clearances)
• DXO — Transducer, Pressure, Catheter Tip (Class II, 64 clearances)
• DXP — Transducer, Vessel Occlusion (Class II, 2 clearances)
• DXQ — Blood Pressure Cuff (Class II, 198 clearances)
• DXR — Ballistocardiograph (Class II, 5 clearances)
• DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass (Class II, 13 clearances)
• DXW — System, Phonocatheter, Intracavitary (Class II, 5 clearances)
• DXX — System, Catheter Control, Steerable (Class II, 33 clearances)
• DXY — Implantable Pacemaker Pulse-Generator (Class III, 461 clearances)
• DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II, 90 clearances)
• DYB — Introducer, Catheter (Class II, 701 clearances)
• DYC — Vectorcardiograph (Class II, 4 clearances)
• DYE — Replacement Heart-Valve (Class III)
• DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (Class II, 21 clearances)
• DYG — Catheter, Flow Directed (Class II, 99 clearances)
• FZC — Prosthesis, Arterial Graft, Bovine Carotid Artery (Class III)
• JOD — Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass (Class II, 12 clearances)
• JOM — Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (Class II, 53 clearances)
• JON — Transducer, Apex Cardiographic (Class II)
• JOO — Transducer, Heart Sound (Class II)
• JOP — Transducer, Ultrasonic (Class II, 72 clearances)
• JOQ — Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) (Class II, 18 clearances)
• JOR — Generator, Pulsatile Flow, Cardiopulmonary Bypass (Class III)
• JOW — Sleeve, Limb, Compressible (Class II, 350 clearances)
• KFJ — Materials, Repair Or Replacement, Pacemaker (Class III, 3 clearances)
• KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (Class II, 84 clearances)
• KPK — Marker, Ostia, Aorto-Saphenous Vein (Class II, 6 clearances)
• KRA — Catheter, Continuous Flush (Class II, 173 clearances)
• KRB — Probe, Thermodilution (Class II, 37 clearances)
• KRC — Tester, Electrode, Surface, Electrocardiographic (Class II, 11 clearances)
• KRD — Device, Vascular, For Promoting Embolization (Class II, 128 clearances)
• KRE — Analyzer, Pacemaker Generator Function, Indirect (Class II, 13 clearances)
• KRF — Charger, Pacemaker (Class I)
• KRG — Programmer, Pacemaker (Class III, 25 clearances)
• KRH — Ring, Annuloplasty (Class II, 74 clearances)
• KRI — Accessory Equipment, Cardiopulmonary Bypass (Class I, 42 clearances)
• KRJ — Filter, Prebypass, Cardiopulmonary Bypass (Class II, 24 clearances)
• KRK — Manometer, Blood-Pressure, Venous (Class II, 9 clearances)
• KRL — Detector, Bubble, Cardiopulmonary Bypass (Class II, 14 clearances)
• LDD — Dc-Defibrillator, Low-Energy, (Including Paddles) (Class II, 166 clearances)
• LDE — Stethoscope, Manual (Class I, 28 clearances)
• LDF — Electrode, Pacemaker, Temporary (Class II, 129 clearances)
• LHX — Trousers, Anti-Shock (Class II, 4 clearances)
• LIT — Catheter, Angioplasty, Peripheral, Transluminal (Class II, 402 clearances)
• LIW — Fibrillator, Ac (Unclassified)
• LIX — Aid, Cardiopulmonary Resuscitation (Class II, 17 clearances)
• LOT — Pulse-Generator, Program Module (Class III)
• LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II, 86 clearances)
• LOZ — Artificial Heart (Class III)
• LPA — System, Esophageal Pacing (Class III)
• LPB — Cardiac Ablation Percutaneous Catheter (Class III)
• LPC — Device, Angioplasty, Laser, Coronary (Class III)
• LWO — Pulse-Generator, Single Chamber, Sensor Driven, Implantable (Class III)
• LWP — Implantable Pulse Generator, Pacemaker (Non-Crt) (Class III)
• LWQ — Heart-Valve, Mechanical (Class III)
• LWR — Heart-Valve, Non-Allograft Tissue (Class III)
• LWS — Implantable Cardioverter Defibrillator (Non-Crt) (Class III)
• LWT — Occluder, Balloon, Vena-Cava (Class III)
• LWW — Pulse-Generator, Single Chamber, Single (Class III)
• LWX — Device. Laser Peripheral Angioplasty (Class III)
• LWZ — Tissue Graft Of Less Than 6mm (Class III, 2 clearances)
• LXA — Tissue Graft Of 6mm And Greater (Class III)
• LXN — Probe, Test, Heart-Valve (Class I, 2 clearances)
• LYK — Angioscope (Class II, 41 clearances)
• MAB — Marker, Cardiopulmonary Bypass (Vein Marker) (Class II, 3 clearances)
• MAD — Catheter, Percutaneous (Valvuloplasty) (Class III)
• MAE — Occluder, Patent Ductus, Arteriosus (Class III)
• MAF — Stent, Coronary (Class III)
• MAL — Graft, Vascular, Synthetic/Biologic Composite (Class II, 6 clearances)
• MAV — Syringe, Balloon Inflation (Class II, 57 clearances)
• MCW — Catheter, Peripheral, Atherectomy (Class II, 146 clearances)
• MCX — Catheter, Coronary, Atherectomy (Class III)
• MFA — Device, Removal, Pacemaker Electrode, Percutaneous (Class III)
• MFX — Vessel Guard Or Cover, To Facilitate Revision Surgeries (Class II, 2 clearances)
• MFY — Endothelial Cell Harvesting Kit (Class II, 1 clearances)
• MGB — Device, Hemostasis, Vascular (Class III)
• MGZ — Valvulotome (Class II, 27 clearances)
• MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (Class II, 422 clearances)
• MIE — Heart-Valve, Allograft (Class III)
• MIH — System, Endovascular Graft, Aortic Aneurysm Treatment (Class III)
• MIR — Shunt, Portosystemic, Endoprosthesis (Class III)
• MJJ — Cpb Check Valve, Retrograde Flow, In-Line (Class II, 9 clearances)
• MJN — Catheter, Intravascular Occluding, Temporary (Class II, 90 clearances)
• MKJ — Automated External Defibrillators (Non-Wearable) (Class III, 228 clearances)
• MLC — Monitor, St Segment (Class II, 2 clearances)
• MLD — Monitor, St Segment With Alarm (Class II, 14 clearances)
• MLN — Electrode, Electrocardiograph, Multi-Function (Class II)
• MLO — Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II, 32 clearances)
• MLV — Transcatheter Septal Occluder (Class III)
• MMX — Device, Percutaneous Retrieval (Class II, 32 clearances)
• MNJ — Valve, Pressure Relief, Cardiopulmonary Bypass (Class II, 2 clearances)
• MNO — System, Laser, Transmyocardial Revascularization (Class III)
• MOM — System, Hemodynamic, Implantable (Class III)
• MOP — Rotator, Prosthetic Heart Valve (Class I, 4 clearances)
• MOU — Intravascular Radiation Delivery System (Class III)
• MPC — Atrial Defibrillator (Class III)
• MPD — Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator (Class II, 3 clearances)
• MPE — Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker (Class II, 1 clearances)
• MRM — Defibrillator, Implantable, Dual-Chamber (Class III)
• MSX — System, Network And Communication, Physiological Monitors (Class II, 117 clearances)
• MTD — Catheter, Intracardiac Mapping, High-Density Array (Class II, 34 clearances)
• MTE — System, Pacing, Temporary, Acute, Internal Atrial Defibrillation (Class III)
• MUQ — Glue, Surgical, Arteries (Class III)
• MVK — Wearable Automated External Defibrillator (Class III)
• MWG — System, Oxygen, Aqueous (Class III)
• MWH — Pulmonic Valved Conduit (HDE)
• MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (Class II, 305 clearances)
• MWJ — Electrocardiograph, Ambulatory (Without Analysis) (Class II, 59 clearances)
• MWS — Stabilizer, Heart (Class I, 4 clearances)
• MXC — Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (Class II, 23 clearances)
• MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (Class II, 33 clearances)
• MZY — Graft, Vascular, Stainless Steel Tunneler (Class II)
• NAP — Cardiac Support Mesh Wrap (Not classified)
• NAV — Graft, Bypass, Coronary Artery (HDE)
• NFA — Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (Class II, 22 clearances)
• NGV — System, Appendage Closure, Left Atrial (Class III)
• NHW — Electrode, Pacing And Cardioversion, Temporary, Epicardial (Class II, 2 clearances)
• NIK — Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (Class III)
• NIM — Stent, Carotid (Class III)
• NIN — Stent, Renal (Class III)
• NIO — Stent, Iliac (Class III)
• NIP — Stent, Superficial Femoral Artery (Class III)
• NIQ — Coronary Drug-Eluting Stent (Class III)
• NIU — Stent, Superficial Femoral Artery, Drug-Eluting (Class III)
• NIV — Coronary Covered Stent (HDE)
• NKE — Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (Class III)
• NKM — Mitral Valve Repair Devices (Class III)
• NKO — System, Balloon, Intra-Aortic And Control, Reprocessed (Class III)
• NKQ — Guidewire, Catheter, Reprocessed (Class II)
• NKR — System, Catheter Control, Reprocessed (Class II)
• NKS — Catheter, Steerable, Reprocessed (Class II)
• NKU — Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed (Class II, 1 clearances)
• NKW — Actuator, Syringe, For Injector, Reprocessed (Class II)
• NLG — Catheter, Intracardiac Mapping, High-Density, Reprocessed (Class II, 3 clearances)
• NLH — Catheter, Recording, Electrode, Reprocessed (Class II, 70 clearances)
• NLI — Catheter, Angiography, Reprocessed (Class II, 1 clearances)
• NLJ — Stripper, Vein, External, Reprocessed (Class II)
• NMB — Catheter, Oximeter, Fiber Optic, Reprocessed (Class II)
• NMD — Oximeter, Tissue Saturation, Reprocessed (Class II, 2 clearances)
• NMF — Clamp, Vascular, Reprocessed (Class II, 3 clearances)
• NMK — Trocar, Reprocessed (Class II, 1 clearances)
• NMM — Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed (Class II)
• NPG — Catheter, Infusion, Syringe (Class II, 1 clearances)
• NPP — Reprocessed Blood Pressure Cuff (Class II, 1 clearances)
• NPS — Tricuspid Valve Repair Device, Percutaneously Delivered (Class III)
• NPT — Aortic Valve, Prosthesis, Percutaneously Delivered (Class III)
• NPU — Prosthesis, Mitral Valve, Percutaneously Delivered (Class III)
• NPV — Pulmonary Valve Prosthesis Percutaneously Delivered (HDE)
• NPW — Percutaneously Delivered Prostheses And Tricuspid Valves (Class III)
• NQG — Stabilizer, Heart, Non-Compression, Reprocessed (Class I, 3 clearances)
• NQH — Sensor, Pressure, Aneurysm, Implantable (Class II, 5 clearances)
• NSA — Over-The-Counter Automated External Defibrillator (Class III, 1 clearances)
• NTE — Temporary Carotid Catheter For Embolic Capture (Class II, 36 clearances)
• NVM — Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon (Class II, 5 clearances)
• NVN — Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (Class III)
• NVY — Permanent Defibrillator Electrodes (Class III)
• NVZ — Pulse Generator, Permanent, Implantable (Class III)
• NWX — Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (Class III)
• NXW — Scaffold, Infrapopliteal, Absorbable (Class III)
• NZE — Hyperthermia Monitor (Class II, 6 clearances)
• OAD — Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (Class III)
• OAE — Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (Class III)
• OBC — Occluder, Internal Vessel, Temporary (Class III)
• OBD — Barrier, Adhesion, Cardiovascular (Class III)
• OBI — Catheter, Pressure Monitoring, Cardiac (Class II, 1 clearances)
• OBJ — Catheter, Ultrasound, Intravascular (Class II, 78 clearances)
• OCH — Oximeter, Infrared, Sporting, Aviation (Class II)
• OCL — Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (Class II, 54 clearances)
• OCM — Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation (Class III)
• ODT — Tissue Adhesive, Aortic Aneurysmorrhaphy (HDE)
• OED — Antimicrobial Blood Pressure Cuff (Class II, 2 clearances)
• OEQ — Angiography/Angioplasty Kit (Class II)
• OER — Angioscopic Valvulotome Kit (Class II)
• OES — Cardiac Catheterization Kit (Class II)
• OET — Cardioplegia Solution Administration Kit (Class II)
• OEU — Cardiopulmonary Bypass Catheter Kit (Class II)
• OEX — Cardiovascular Catheter Sheath Introducer Kit (Class II)
• OEZ — Cardiovascular Procedure Kit (Class II)
• OFA — Cardiovascular Surgical Instruments Tray (Class I)
• OFB — Catheter Guide Wire Kit (Class II)
• OFC — Catheter Introducer Kit (Class II, 1 clearances)
• OFD — Catheter Introducer Kit (Class II)
• OFE — Central Venous Blood Pressure Kit (Class II)
• OFF — Central Venous Catheter Tray (Class II)
• OFG — Ct Biopsy Tray (Class II)
• OFH — Digital Angiography Tray (Class II)
• OFI — Laser Blood Flow Kit (Class II)
• OFJ — Lead Introducer Kit (Class II)
• OFK — Percutaneous Atrial Catheter Kit (Class II)
• OFL — Percutaneous Sheath Introducer Kit (Class II)
• OFN — Winged Intravenous Catheterization Kit (Class II)
• OGZ — Catheter, Intravascular, Plaque Morphology Evaluation (Class II, 9 clearances)
• OHA — Heart Valve, More Than Minimally Manipulated Allograft (Unclassified, 4 clearances)
• OJE — Right Ventricular Bypass (Assist) Device (HDE)
• OJX — Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (Class III)
• OKR — Ventricular Bypass (Assist) Device (Class III)
• OMH — Pericardial Patch To Facilitate Revision Surgeries (Class II, 1 clearances)
• OMR — Vessel Guard Or Cover (Class II, 10 clearances)
• OMZ — Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter (Class II, 5 clearances)
• ONU — Drug-Eluting Peripheral Transluminal Angioplasty Catheter (Class III)
• OOB — Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter (Class III)
• ORD — Optical Coherence Tomography, Intravascular Catheter (Class II)
• OSR — Pacemaker/Icd/Crt Non-Implanted Components (Class III)
• OTD — Endovascular Suturing System (Class II, 7 clearances)
• OVJ — Pulse Generator, External Pacemaker, Dual Chamber (Class II)
• OWQ — Reprocessed Intravascular Ultrasound Catheter (Class II, 30 clearances)
• OZD — Temporary Non-Roller Type Left Heart Support Blood Pump (Class III)
• OZG — Transcatheter Septal Occluder (Atrial) (Class III)
• OZH — Transcatheter Septal Occluder (Ventricular) (Class III)
• OZT — Balloon Aortic Valvuloplasty (Class II, 22 clearances)
• OZW — Ingestible Event Marker (Class II, 8 clearances)
• PAL — Pulmonic Replacement Heart Valve (HDE)
• PAP — Aortic Heart Valve, More Than Minimally Manipulated Allograft (HDE)
• PAW — Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement (Class II, 3 clearances)
• PCK — Pediatric Ventricular Assist Device (HDE)
• PCW — Implantable Pulse Generator, Programmer And Battery Charger (Not classified)
• PCX — Artificial Chordae Tendinae Delivery System (Not classified)
• PDU — Catheter For Crossing Total Occlusions (Class II, 57 clearances)
• PFA — Non-Invasive Central Venous Manometer (Class II, 2 clearances)
• PFV — System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment (Class III)
• PFY — Low Patient Acuity Monitoring System (Class II)
• PIZ — Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve (Class III)
• PJA — Coronary Vascular Physiologic Simulation Software (Class II, 9 clearances)
• PJB — Catheter Remote Control System (Class II, 4 clearances)
• PJQ — Agent, Occluding, Vascular, Permanent (Class III)
• PKK — Stent Delivery System (Not classified)
• PLA — Esophageal Thermal Regulation And Gastric Suctioning Device (Class II, 9 clearances)
• PLB — Multivariate Vital Signs Index (Class II, 8 clearances)
• PMJ — Cpr Aid Feedback Device (No Software) (Class II)
• PMK — Cpr Aid Device Without Feedback (Class I, 2 clearances)
• PNE — Reprocessed Catheter Introducer (Class II, 7 clearances)
• PNF — Aortic Stent (Class III)
• PNJ — Leadless Pacemaker (Class III)
• PNO — Catheter, Percutaneous, Cutting/Scoring (Class II, 45 clearances)
• PNQ — Apical Closure Device (Class II, 1 clearances)
• PNS — Short-Term Intravascular Filter Catheter (Class II, 1 clearances)
• PNY — Absorbable Coronary Drug-Eluting Stent (Class III)
• PPN — Percutaneous Catheter, Ultrasound (Class II, 12 clearances)
• PPS — Sleeve, Head And Neck, Compressible (Class II, 1 clearances)
• PPW — Adjunctive Cardiovascular Status Indicator (Class II, 8 clearances)
• PQK — Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access (Class II, 7 clearances)
• PRC — Drug-Coated Peripheral Transluminal Angioplasty Catheter (Class III)
• PRL — Iliac Covered Stent, Arterial (Class III)
• PSQ — Intracardiac Patch Or Pledget, Biologically Derived (Class II, 11 clearances)
• PST — Aortic Annuloplasty Ring (Class II, 2 clearances)
• PTL — Wire, Guide, Catheter, Exempt (Class II)
• PTM — Syringe, Balloon Inflation, Exempt (Class II)
• PTN — Reservoir, Blood, Cardiopulmonary Bypass, Exempt (Class II)
• PUM — Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures (Class II, 2 clearances)
• PYX — Temporary Non-Roller Type Right Heart Support Blood Pump (Class III)
• PZO — Software For Visualization Of Vascular Anatomy And Intravascular Devices (Class II, 10 clearances)
• PZS — Dual Lumen Ecmo Cannula (Class II, 4 clearances)
• PZX — Left Atrial Appendage Clip, Implantable (Class II, 8 clearances)
• QAB — Pacing System Analyzer (Class II)
• QAN — Stent, Iliac Vein (Class III)
• QAQ — Adjunctive Predictive Cardiovascular Indicator (Class II, 5 clearances)
• QBI — Acute Coronary Syndrome Event Detector (Class III)
• QCT — Scaffold, Dissection Repair (Class III)
• QDA — Electrocardiograph Software For Over-The-Counter Use (Class II, 9 clearances)
• QDB — Photoplethysmograph Analysis Software For Over-The-Counter Use (Class II, 5 clearances)
• QEK — Angiographic Coronary Vascular Physiologic Simulation Software (Class II, 2 clearances)
• QEW — Peripheral Mechanical Thrombectomy With Aspiration (Class II, 141 clearances)
• QEX — Coronary Mechanical Thrombectomy With Aspiration (Class II, 3 clearances)
• QEY — Mechanical Thrombolysis Catheter (Class II, 71 clearances)
• QEZ — Aspiration Thrombectomy Catheter (Class II, 92 clearances)
• QFJ — Intravascular Bleed Monitor (Class II, 2 clearances)
• QFV — Implantable Pulse Generator (Class III)
• QHW — Single Lumen Ecmo Cannula (Class II, 3 clearances)
• QIK — Organ Care System (Ocs) Heart System (Class III)
• QJH — Reverse Central Venous Recanalization System (Class II, 2 clearances)
• QJZ — Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure (Class II, 3 clearances)
• QKJ — Stent, Central Venous (Class III)
• QLJ — Patient Monitor With Independent Remote Display And Operation (Not classified)
• QLL — Left Ventricular Ejection Fraction Screening Tool (Not classified)
• QLM — Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool (Not classified)
• QLN — Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19 (Not classified)
• QLZ — Septostomy Catheter, Reprocessed (Class II, 2 clearances)
• QME — Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate (Class II, 10 clearances)
• QMG — Shockwave Intravascular Lithotripsy System (Class III)
• QMS — Adjunctive Open Loop Fluid Therapy Recommender (Class II, 2 clearances)
• QMW — Coronary Artery Disease Risk Indicator From Acoustic Heart Signals (Class II, 1 clearances)
• QNL — Medium-Term Adjunctive Predictive Cardiovascular Indicator (Class II, 5 clearances)
• QNR — Blood Pump For Ecmo, Long-Term (> 6 Hours) Use (Class II, 8 clearances)
• QNV — Adjunctive Hemodynamic Indicator With Decision Point (Class II, 3 clearances)
• QNY — Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring (Not classified)
• QNZ — Powered Communication System For Emergency Use (Not classified)
• QOA — Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening (Not classified)
• QOC — Temporary Non-Roller Type Left Or Right Heart Support Blood Pump (Not classified)
• QOD — Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure (Not classified)
• QOH — Extracorporeal System For Carbon Dioxide Removal (Class II, 1 clearances)
• QOK — Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate (Class II, 1 clearances)
• QQI — Interventional Cardiovascular Implant Simulation Software Device (Class II, 4 clearances)
• QRJ — Laser-Powered Inferior Vena Cava Filter Retrieval Catheter (Class II, 1 clearances)
• QSK — Hybrid Stent Graft, Thoracic Aortic Lesion Treatment (Class III)
• QTF — Reprocessed Atherectomy Catheter (Class II, 1 clearances)
• QUO — Adjunctive Heart Failure Status Indicator (Class II, 4 clearances)
• QVG — Embolization Agent, Vascular (Class III)
• QVQ — Extravascular Support For An Arteriovenous Fistula For Vascular Access (Class II, 2 clearances)
• QWA — Cardiovascular Delivery Catheter System Positioning And Stabilization Device (Class I)
• QWC — Pulmonary Stent (Class III)
• QWF — Tubing, Long Term Support Greater Than 6 Hours (Class II, 1 clearances)
• QWM — Stent Graft, Bypass, Superficial Femoral Artery (Class III)
• QWN — Stent Graft, Infrapopliteal, Venous Arterialization (Class III)
• QXO — Cardiovascular Machine Learning-Based Notification Software (Class II, 1 clearances)
• QXU — Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation (Class II, 2 clearances)
• QXV — Temperature Regulation Device For Esophageal Protection During Cardiac Ablation (Class II, 1 clearances)
• QXX — Coronary Artery Disease Machine Learning-Based Notification Software (Class II, 1 clearances)
• QXY — Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature (Class II, 1 clearances)
• QXZ — Adjunctive Epicardial Vascular Physiologic Status Indicator (Class II, 1 clearances)
• QYE — Reduced Ejection Fraction Machine Learning-Based Notification Software (Class II, 5 clearances)
• QYF — Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms) (Class II)
• QYI — Ablation Catheter, Renal Denervation (Class III)
• QYU — Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use (Class II, 2 clearances)
• QYW — Hospital Cardiac Telemetry (Class II, 2 clearances)
• QYX — Outpatient Cardiac Telemetry (Class II, 21 clearances)
• QZI — Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (Class III)
• QZK — Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions (Class III)
• QZU — Temporary Embolization Assist Device, Peripheral (Class II, 1 clearances)
• SAR — Adjunctive Hemodynamic Indicator With Decision Point For Military Use (Class II, 1 clearances)
• SAT — Pulmonary Hypertension Machine Learning-Based Notification Software (Class II, 2 clearances)
• SBK — Artificial Chordae Tendineae Surgical Replacement System (Class II, 1 clearances)
• SBQ — Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software (Class II, 1 clearances)
• SCZ — Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures (Class II, 1 clearances)
• SDJ — Adjunctive Cardiac Amyloidosis Status Indicator (Class II, 3 clearances)
• SDY — Loss Of Pulse Notification Software (Class II, 1 clearances)
• SDZ — Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions (Class III)
• SEG — Leadless Cardiac Resynchronization Therapy (Crt) (Class III)
• SEQ — Covered Stent Vascular Connector, Hemodialysis Access Circuit (Class III)
• SEU — Peripheral Temporary And Retrievable Stent System (Class II, 1 clearances)
• SFQ — Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision (Class II)
• SFR — Hypertension Machine Learning-Based Notification Software (Class II, 1 clearances)
• SGO — Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures (Class II, 1 clearances)
• SHP — Cardiac Amyloidosis Machine Learning-Based Notification Software (Class II, 1 clearances)
• SHR — Device For Open Surgical Explant Of Endovascular Prostheses (Class II, 1 clearances)
• SIF — Software Device System For Estimation Of Cardiac Pressures (Class II)
• SII — Aortic Stenosis Machine Learning-Based Notification Software (Class II)
• SIJ — Valvular Regurgitation Machine Learning-Based Notification Software (Class II)
• SIK — Cardiac Hypertrophy Machine Learning-Based Notification Software (Class II)
• SIU — Predictive Indicator For Long-Term Cardiovascular Outcomes (Class II)