Skip to content
De Novo DEN170064
- Device
- Comaneci, Comaneci Petit, Comaneci 17
- Contact
- orit yaniv
- De Novo number
- DEN170064
- Product code
- PUU
- Regulation
- 882.5955
- Classification name
- temporary coil embolization assist device
- Decision
- granted (DENG)
- Decision date
- 2019-04-24
- Date received
- 2017-09-28
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- PUU
- Device name
- Temporary Coil Embolization Assist Device
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5955
- Implant
- N
- Life sustain/support
- N