510(k) K252364 ยท DYB Introducer, Catheter
Edwards eSheath Optima introducer set
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 29, 2025 |
| Received | Jul 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252364
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.