Product code
PAV: Catheter, neuro-vasculature, occluding balloon
FDA product code · HDE · Neurology
Key facts
| Product code | PAV |
|---|---|
| Device | Catheter, neuro-vasculature, occluding balloon |
| Device class | HDE |
| Regulation number | 882.5150 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Used to obstruct lower aortic blood flow to augment cerebral perfusion. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- None UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database