510(k) DEN210024
- Device
- CavaClear Laser Sheath
- Applicant
- Spectranetics, Inc.
- 510(k) number
- DEN210024
- Product code
- QRJ
- Decision
- Unknown (DENG)
- Decision date
- 2021-12-21
- Date received
- 2021-06-25
- Regulation
- 870.5125
- Classification name
- Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sondra Chandler
- Address
- 9965 Federal Dr. Colorado Springs CO US 80921 80921
FDA Registration Numbers#
- 1724474
- 3007284006
- 1721676
Source Documents#
510(k) summary PDF not indicated by FDA