510(k) DEN210024
DEN210024 is an FDA 510(k) premarket notification submitted by Spectranetics, Inc. for the device "CavaClear Laser Sheath". The FDA issued a decision of De Novo Granted on December 21, 2021. The device falls under product code QRJ (Laser-Powered Inferior Vena Cava Filter Retrieval Catheter), a Class II device regulated under 21 CFR 870.5125. Spectranetics, Inc. has at least 10 other 510(k) clearances on record.
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.