FDA product code PVM: Endoscopic Ventricular Catheter Placement Kit
PVM is the FDA product code for endoscopic ventricular catheter placement kit. It is a Class II device, regulated under 21 CFR 882.4100 and reviewed by the Neurology panel. Devices under PVM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Ventricular Catheter Placement Kit |
| Device class | Class II |
| Regulation | 21 CFR 882.4100 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for PVM devices
openFDA lists no recalls for product code PVM.
Frequently asked questions
What is FDA product code PVM?
PVM is the FDA product code for endoscopic ventricular catheter placement kit. It is a Class II device, regulated under 21 CFR 882.4100 and reviewed by the Neurology panel.
What device class is PVM?
Class II, regulation 21 CFR 882.4100. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PVM
- Run a recall and safety report across every PVM manufacturer
- Watch product code PVM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.