FDA product code QRJ: Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
QRJ is the FDA product code for laser-powered inferior vena cava filter retrieval catheter. It is a Class II device, regulated under 21 CFR 870.5125 and reviewed by the Cardiovascular panel. Devices under QRJ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters.
Classification
| Field | Value |
|---|---|
| Device name | Laser-Powered Inferior Vena Cava Filter Retrieval Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.5125 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for QRJ devices
openFDA lists no recalls for product code QRJ.
Frequently asked questions
What is FDA product code QRJ?
QRJ is the FDA product code for laser-powered inferior vena cava filter retrieval catheter. It is a Class II device, regulated under 21 CFR 870.5125 and reviewed by the Cardiovascular panel.
What device class is QRJ?
Class II, regulation 21 CFR 870.5125. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QRJ
- Run a recall and safety report across every QRJ manufacturer
- Watch product code QRJ 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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