DEN210024 is an FDA 510(k) submission for the CavaClear Laser Sheath. This device is classified as a Laser-powered Inferior Vena Cava Filter Retrieval Catheter (Class II - Special Controls, product code QRJ).
Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Not Cleared (DENG) decision on December 21, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5125. 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..
| 510(k) Number | DEN210024 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 25, 2021 |
| Decision Date | December 21, 2021 |
| Days to Decision | 179 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | QRJ - Laser-powered Inferior Vena Cava Filter Retrieval Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5125 |
| 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. |