QRJ · Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
Cardiovascular · 21 CFR 870.5125 · Class 2
Overview
| Product Code | QRJ |
|---|---|
| Device Name | Laser-Powered Inferior Vena Cava Filter Retrieval Catheter |
| Regulation | 21 CFR 870.5125 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
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. The CavaClear Laser Sheath is intended for the ablation of tissue in the removal of IVC filters that have failed a previous retrieval method.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act. the laser-powered inferior vena cava (IVC) filter retrieval catheter is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN210024 | CavaClear Laser Sheath | Spectranetics, Inc. | Dec 21, 2021 | DENG |
Top Applicants
- Spectranetics, Inc. — 1 clearance
