FDA product code PAV: Catheter, Neuro-Vasculature, Occluding Balloon
PAV is the FDA product code for catheter, neuro-vasculature, occluding balloon. It is a HDE device, regulated under 21 CFR 882.5150 and reviewed by the Neurology panel. Devices under PAV reach the market by Unclassified; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for PAV devices.
Definition
Used to obstruct lower aortic blood flow to augment cerebral perfusion.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Neuro-Vasculature, Occluding Balloon |
| Device class | HDE |
| Regulation | 21 CFR 882.5150 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | Unclassified |
Recalls for PAV devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-04-01.
Frequently asked questions
What is FDA product code PAV?
PAV is the FDA product code for catheter, neuro-vasculature, occluding balloon. It is a HDE device, regulated under 21 CFR 882.5150 and reviewed by the Neurology panel.
What device class is PAV?
HDE, regulation 21 CFR 882.5150. Typical premarket route: Unclassified.
Have PAV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code PAV
- Run a recall and safety report across every PAV manufacturer
- Watch product code PAV 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.
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