Mi-CHORD System
FDA 510(k) clearance DEN230069 · decided 2024-06-11
Clearance details
- K-number
- DEN230069
- Device name
- Mi-CHORD System
- Applicant
- Lsi Solutions, Inc.
- Decision
- Unknown
- Date received
- 2023-09-29
- Decision date
- 2024-06-11
- Days to decision
- 256 days
- Clearance type
- Direct
- Product code
- SBK
- Device class
- 2
- Regulation number
- 870.3490
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Victor, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.