510(k) K131627 ยท DYB Introducer, Catheter
CATHETER INTRODUCER SHEATH
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Mar 6, 2014 |
| Received | Jun 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131627
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.