K232599
- 510(k) number
- K232599
- Device name
- TransForm McCarthy Mitral Annuloplasty Ring (TF)
- Applicant
- Genesee Biomedical, Inc. CO · US
- Product code
- KRH — Ring, Annuloplasty
- Decision date
- 2024-04-09
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K232599.pdf
Official FDA record: K232599
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.