FDA product code QWN: Stent Graft, Infrapopliteal, Venous Arterialization
QWN is the FDA product code for stent graft, infrapopliteal, venous arterialization. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QWN reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
For performing percutaneous arterialization of the deep veins to restore blood flow in the lower limbs
Classification
| Field | Value |
|---|---|
| Device name | Stent Graft, Infrapopliteal, Venous Arterialization |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for QWN devices
openFDA lists no recalls for product code QWN.
Frequently asked questions
What is FDA product code QWN?
QWN is the FDA product code for stent graft, infrapopliteal, venous arterialization. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QWN?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QWN
- Run a recall and safety report across every QWN manufacturer
- Watch product code QWN 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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