510(k) K060487 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 23, 2006 |
| Received | Feb 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060487
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.