FDA product code QWM: Stent Graft, Bypass, Superficial Femoral Artery
QWM is the FDA product code for stent graft, bypass, superficial femoral artery. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QWM reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
For bypassing stenosis in the superficial femoral artery via the femoral vein
Classification
| Field | Value |
|---|---|
| Device name | Stent Graft, Bypass, Superficial Femoral Artery |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QWM devices
openFDA lists no recalls for product code QWM.
Frequently asked questions
What is FDA product code QWM?
QWM is the FDA product code for stent graft, bypass, superficial femoral artery. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QWM?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QWM
- Run a recall and safety report across every QWM manufacturer
- Watch product code QWM 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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