De Novo DEN190038
- Device
- Surfacer Inside-Out Access Catheter System
- Contact
- gabriele g. niederauer
- De Novo number
- DEN190038
- Product code
- QJH
- Regulation
- 870.1342
- Classification name
- reverse central venous recanalization system
- Decision
- granted (DENG)
- Decision date
- 2020-02-10
- Date received
- 2019-08-15
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QJH
- Device name
- Reverse Central Venous Recanalization System
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.1342
- Implant
- N
- Life sustain/support
- N