510(k) K152225 ยท DYB Introducer, Catheter
Edwards eSheath Introducer Set
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 24, 2015 |
| Received | Aug 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152225
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.