510(k) K162184 ยท DYB Introducer, Catheter
Edwards eSheath Introducer Set
| Applicant | Edward Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 2, 2016 |
| Received | Aug 4, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162184
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.