K250859
- 510(k) number
- K250859
- Device name
- TransForm McCarthy Mitral Annuloplasty Ring (TF)
- Applicant
- Genesee Biomedical, Inc. CO · US
- Product code
- KRH — Ring, Annuloplasty
- Decision date
- 2025-07-25
- Date received
- 2025-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 5.5 MB · U.S. public domain
Also available from FDA: K250859.pdf
Official FDA record: K250859
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.