De Novo DEN250042
- Device
- CaRi-Heart
- Contact
- frank cheng
- De Novo number
- DEN250042
- Product code
- SIU
- Regulation
- 870.2215
- Classification name
- predictive indicator for long-term cardiovascular outcomes
- Decision
- granted (DENG)
- Decision date
- 2026-07-28
- Date received
- 2025-09-04
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct