510(k) K251688 ยท KRH Ring, Annuloplasty
Carpentier-Edwards Physio Annuloplasty Ring (4450)
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 17, 2025 |
| Received | Jun 2, 2025 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K251688
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.