Guidant Corp.: FDA filings under this applicant name
FDA lists 86 510(k) clearances under the applicant name “Guidant Corp.” (first 1997, latest 2006), plus 3 PMA decisions, across 17 product codes in 3 review panels. Median 510(k) review time under this name: 34 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 27 | 27 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 20 | 20 |
| DQY | Catheter, Percutaneous | 14 | 14 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 4 | 4 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 4 | 4 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 4 | 4 |
| DRB | Stylet, Catheter | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
Plus 7 more product codes.
Review panels
Most recent Guidant Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061865 | FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 | NEY | 2006-07-27 | 24 |
| K061453 | HI-TORQUE WHISPER VIEW GUIDE WIRE | DQX | 2006-06-22 | 28 |
| K060449 | HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE | DQX | 2006-05-30 | 98 |
| K053459 | OMNILINK .035 BILIARY STENT SYSTEM | FGE | 2006-04-12 | 120 |
| K053454 | RX HERCULINK ELITE BILIARY STENT SYSTEM | FGE | 2006-03-06 | 87 |
| K053019 | ACUITY STEERABLE STYLET ACCESSORY | DRB | 2006-03-03 | 128 |
| K052965 | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. | DRB | 2006-02-13 | 115 |
| K052274 | GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 | GEI | 2005-09-21 | 30 |
| K052166 | MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM | NTE | 2005-08-18 | 9 |
| K052165 | RX ACCUNET EMBOLIC PROTECTION SYSTEM | NTE | 2005-08-16 | 7 |
76 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050046 | PMA | ACUITY STEERABLE LEAD SYSTEM | 2007-04-13 |
| P030005 | PMA | CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE | 2004-01-26 |
| P000052 | PMA | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM | 2001-11-02 |
Recalls
42 product recalls in 14 recall events; 0 initiated in the last five years. Most recent: 2006-09-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Guidant Corp. is the lead sponsor of 13 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01227785: Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study (Completed, started 2010-10)
- NCT00833352: Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device (Completed, started 2008-11)
- NCT00606710: Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following (Completed, started 2008-02)
- NCT00409604: PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s) (Completed, started 2006-12)
- NCT00292539: Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class (Completed, started 2006-02)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Guidant Corporation, Cardiac Surgery (8 510(k)s)
- Guidant Cardiac and Vascular Surgery (7 510(k)s)
- Guidant Endovascular Solutions, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guidant Corp.?
FDA lists 86 510(k) clearances under the applicant name “Guidant Corp.” (first 1997, latest 2006), plus 3 PMA decisions, across 17 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Guidant Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guidant Corp. is 34 days.
Which FDA product codes appear under Guidant Corp.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 27); FGE (Stents, Drains And Dilators For The Biliary Ducts, 20); DQY (Catheter, Percutaneous, 14).
Next steps
- See all 86 Guidant Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Guidant Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.