Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
The Laser-Powered Inferior Vena Cava Filter Retrieval Catheter is a percutaneous catheter that uses laser energy to ablate adherent tissue, facilitating the detachment and removal of indwelling inferior vena cava (IVC) filters that could not otherwise be retrieved. It addresses the clinical problem of chronically embedded IVC filters that pose long-term risks. Classified as FDA Class 2 under regulation 870.5125, it requires 510(k) clearance and is reviewed under the Cardiovascular medical specialty. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QRJ
- Device Class
- FDA class 2
- Regulation Number
- 870.5125
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN210024 | CavaClear Laser Sheath | Dec 21, 2021 | Unknown | Spectranetics, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.