De Novo DEN160043
- Device
- Sentinel Cerebral Protection System
- Contact
- zachary woodson
- De Novo number
- DEN160043
- Product code
- PUM
- Regulation
- 870.1251
- Classification name
- temporary catheter, embolic protection, transcatheter intracardiac procedures
- Decision
- granted (DENG)
- Decision date
- 2017-06-01
- Date received
- 2016-09-20
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- PUM
- Device name
- Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.1251
- Implant
- N
- Life sustain/support
- N