510(k) K031087 ยท DYB Introducer, Catheter
EDWARDS INTRODUCER SHEATH
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 24, 2003 |
| Received | Apr 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031087
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.