FDA product code PCK: Pediatric Ventricular Assist Device
PCK is the FDA product code for pediatric ventricular assist device. It is a HDE device, regulated under 21 CFR 870.3545 and reviewed by the Cardiovascular panel. Devices under PCK reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
Classification
| Field | Value |
|---|---|
| Device name | Pediatric Ventricular Assist Device |
| Device class | HDE |
| Regulation | 21 CFR 870.3545 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | Unclassified |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for PCK devices
openFDA lists no recalls for product code PCK.
Frequently asked questions
What is FDA product code PCK?
PCK is the FDA product code for pediatric ventricular assist device. It is a HDE device, regulated under 21 CFR 870.3545 and reviewed by the Cardiovascular panel.
What device class is PCK?
HDE, regulation 21 CFR 870.3545. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PCK
- Run a recall and safety report across every PCK manufacturer
- Watch product code PCK 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.