QRJ — Laser-Powered Inferior Vena Cava Filter Retrieval Catheter Class II
FDA product code QRJ covers "Laser-Powered Inferior Vena Cava Filter Retrieval Catheter", a Class II medical device regulated under 21 CFR 870.5125. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QRJ
- Device Class
- Class II
- Regulation Number
- 870.5125
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210024 | spectranetics | CavaClear Laser Sheath | December 21, 2021 |