510(k) K244046 ยท DYB Introducer, Catheter
Edwards eSheath Optima introducer set
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 27, 2025 |
| Received | Dec 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K244046
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.