510(k) K093554 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
RETROFLEX DILATOR KIT
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 13, 2010 |
| Received | Nov 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093554
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.