510(k) K200258 ยท DYB Introducer, Catheter
Edwards eSheath Introducer Set
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 9, 2020 |
| Received | Feb 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200258
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.