510(k) K011039 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
OMNILINK .018 BILIARY STENT SYSTEM
| Applicant | Guidant Corp., Santa Clara CA, US |
| Decision | Unknown, May 8, 2001 |
| Received | Apr 5, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011039
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2005 | Guidant Endovascular Solutions, Inc. Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.