510(k) K250859 ยท KRH Ring, Annuloplasty
TransForm McCarthy Mitral Annuloplasty Ring (TF)
| Applicant | Genesee Biomedical, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Jul 25, 2025 |
| Received | Mar 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250859
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.