Product code
PNQ: Apical closure device
FDA product code · Class II · Cardiovascular
Key facts
| Product code | PNQ |
|---|---|
| Device | Apical closure device |
| Device class | Class II |
| Regulation number | 870.4510 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | This device is intended for closure of cardiac apical tissue. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None 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