FDA product code NAV: Graft, Bypass, Coronary Artery
NAV is the FDA product code for graft, bypass, coronary artery. It is a HDE device, reviewed by the Cardiovascular panel. Devices under NAV reach the market by Unclassified; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for NAV devices.
Classification
| Field | Value |
|---|---|
| Device name | Graft, Bypass, Coronary Artery |
| Device class | HDE |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NAV devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-06-24.
Frequently asked questions
What is FDA product code NAV?
NAV is the FDA product code for graft, bypass, coronary artery. It is a HDE device, reviewed by the Cardiovascular panel.
What device class is NAV?
HDE. Typical premarket route: Unclassified.
Have NAV devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2011-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code NAV
- Run a recall and safety report across every NAV manufacturer
- Watch product code NAV 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.
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