FDA product code FZC: Prosthesis, Arterial Graft, Bovine Carotid Artery
FZC is the FDA product code for prosthesis, arterial graft, bovine carotid artery. It is a Class III device, reviewed by the Cardiovascular panel. Devices under FZC reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Arterial Graft, Bovine Carotid Artery |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for FZC devices
openFDA lists no recalls for product code FZC.
Frequently asked questions
What is FDA product code FZC?
FZC is the FDA product code for prosthesis, arterial graft, bovine carotid artery. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is FZC?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code FZC
- Run a recall and safety report across every FZC manufacturer
- Watch product code FZC 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.