FDA product code PNQ: Apical Closure Device
PNQ is the FDA product code for apical closure device. It is a Class II device, regulated under 21 CFR 870.4510 and reviewed by the Cardiovascular panel. Devices under PNQ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
This device is intended for closure of cardiac apical tissue.
Classification
| Field | Value |
|---|---|
| Device name | Apical Closure Device |
| Device class | Class II |
| Regulation | 21 CFR 870.4510 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for PNQ devices
openFDA lists no recalls for product code PNQ.
Frequently asked questions
What is FDA product code PNQ?
PNQ is the FDA product code for apical closure device. It is a Class II device, regulated under 21 CFR 870.4510 and reviewed by the Cardiovascular panel.
What device class is PNQ?
Class II, regulation 21 CFR 870.4510. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PNQ
- Run a recall and safety report across every PNQ manufacturer
- Watch product code PNQ 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.