510(k) K052132 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 24, 2005 |
| Received | Aug 5, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052132
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.