DEN230069
- 510(k) number
- DEN230069
- Device name
- Mi-CHORD System
- Applicant
- Lsi Solutions, Inc. NY · US
- Product code
- SBK — Artificial Chordae Tendineae Surgical Replacement Sy
- Decision date
- 2024-06-11
- Date received
- 2023-09-29
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN230069
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.