De Novo DEN230064
- Device
- BraidE Embolization Assist Device
- Contact
- ina gutman
- De Novo number
- DEN230064
- Product code
- QZU
- Regulation
- 870.3325
- Classification name
- temporary embolization assist device, peripheral
- Decision
- granted (DENG)
- Decision date
- 2024-02-21
- Date received
- 2023-09-19
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QZU
- Device name
- Temporary Embolization Assist Device, Peripheral
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.3325
- Implant
- N
- Life sustain/support
- N