FDA product code QAN: Stent, Iliac Vein
QAN is the FDA product code for stent, iliac vein. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QAN reach the market by PMA; FDA lists no cleared 510(k)s for it. 6 PMA applications cite this product code. FDA has posted 9 recalls for QAN devices, 3 initiated in the last five years.
Definition
A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Classification
| Field | Value |
|---|---|
| Device name | Stent, Iliac Vein |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for QAN devices
9 product recalls in 6 recall events; 3 initiated in the last five years and 7 still open. Most recent: 2025-12-04.
| Year | Recalls |
|---|---|
| 2020 | 3 |
| 2021 | 4 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code QAN?
QAN is the FDA product code for stent, iliac vein. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QAN?
Class III. Typical premarket route: PMA.
Have QAN devices been recalled?
Yes: 9 product recalls across 6 recall events; the most recent began 2025-12-04.
Next steps
- Run an FDA pathway report with predicate devices for product code QAN
- Run a recall and safety report across every QAN manufacturer
- Watch product code QAN 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times