510(k) K123714 ยท DYB Introducer, Catheter
EDWARDS EMBOL-X INTRODUCER SHEATH
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Jul 24, 2013 |
| Received | Dec 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123714
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.