Product code
PUM: Temporary catheter, embolic protection, transcatheter intracardiac procedures
FDA product code · Class II · Cardiovascular
Key facts
| Product code | PUM |
|---|---|
| Device | Temporary catheter, embolic protection, transcatheter intracardiac procedures |
| Device class | Class II |
| Regulation number | 870.1251 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Embolic protection for transcatheter intracardiac procedures |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- None 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