De Novo DEN210024
- Device
- CavaClear Laser Sheath
- Contact
- sondra chandler
- De Novo number
- DEN210024
- Product code
- QRJ
- Regulation
- 870.5125
- Classification name
- laser-powered inferior vena cava filter retrieval catheter
- Decision
- granted (DENG)
- Decision date
- 2021-12-21
- Date received
- 2021-06-25
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QRJ
- Device name
- Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.5125
- Implant
- N
- Life sustain/support
- N