The following data is part of a De Novo classification by Spectranetics, Inc. with the FDA for Cavaclear Laser Sheath.
| DeNovo ID | DEN210024 |
| Device Name: | CavaClear Laser Sheath |
| Classification | Laser-powered Inferior Vena Cava Filter Retrieval Catheter |
| Applicant | Spectranetics, Inc. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Sondra Chandler |
| Product Code | QRJ |
| CFR Regulation Number | 870.5125 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Cardiovascular |
| Classification Advisory | Cardiovascular |
| Type | Direct |
| Date Received | 2021-06-25 |
| Decision Date | 2021-12-21 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132022976 | DEN210024 | 000 |
| 00813132022969 | DEN210024 | 000 |