Skip to contentDe Novo DEN200030
- Device
- FEops HEARTguide
- Contact
- sofie van cauter
- De Novo number
- DEN200030
- Product code
- QQI
- Regulation
- 870.1405
- Classification name
- interventional cardiovascular implant simulation software device
- Decision
- granted (DENG)
- Decision date
- 2021-09-08
- Date received
- 2020-05-07
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QQI
- Device name
- Interventional Cardiovascular Implant Simulation Software Device
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.1405
- Implant
- N
- Life sustain/support
- N