FDA product code QWC: Pulmonary Stent
QWC is the FDA product code for pulmonary stent. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QWC reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
A pulmonary stent is a metal scaffold placed via a delivery catheter into the pulmonary artery to maintain the lumen.
Classification
| Field | Value |
|---|---|
| Device name | Pulmonary Stent |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QWC devices
openFDA lists no recalls for product code QWC.
Frequently asked questions
What is FDA product code QWC?
QWC is the FDA product code for pulmonary stent. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QWC?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QWC
- Run a recall and safety report across every QWC manufacturer
- Watch product code QWC 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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