510(k) DEN210024
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 21, 2021
- Date Received
- June 25, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
- Device Class
- Class II
- Regulation Number
- 870.5125
- Review Panel
- CV
- Submission Type
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.