510(k) K093877 ยท DYB Introducer, Catheter
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 1, 2010 |
| Received | Dec 16, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093877
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.