510(k) K030944 ยท DYB Introducer, Catheter
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 20, 2003 |
| Received | Mar 26, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030944
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.