510(k) K141696 ยท DYB Introducer, Catheter
EDWARDS ESHEATH INTRODUCER SET
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 18, 2014 |
| Received | Jun 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141696
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.