510(k) K121185 ยท DYB Introducer, Catheter
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Aug 22, 2012 |
| Received | Apr 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121185
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.