510(k) K251982 ยท KRH Ring, Annuloplasty
Edwards MC3 Tricuspid annuloplasty ring (4900)
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 23, 2025 |
| Received | Jun 27, 2025 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K251982
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.