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De Novo DEN230069
- Device
- Mi-CHORD System
- Contact
- christopher b. miller
- De Novo number
- DEN230069
- Product code
- SBK
- Regulation
- 870.3490
- Classification name
- artificial chordae tendineae surgical replacement system
- Decision
- granted (DENG)
- Decision date
- 2024-06-11
- Date received
- 2023-09-29
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- SBK
- Device name
- Artificial Chordae Tendineae Surgical Replacement System
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.3490
- Implant
- Y
- Life sustain/support
- Y