TransForm McCarthy Mitral Annuloplasty Ring (TF)
FDA 510(k) clearance K232599 · decided 2024-04-09
Clearance details
- K-number
- K232599
- Device name
- TransForm McCarthy Mitral Annuloplasty Ring (TF)
- Applicant
- Genesee Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-28
- Decision date
- 2024-04-09
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- KRH
- Device class
- 2
- Regulation number
- 870.3800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Denver, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.