510(k) K941350 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Mar 9, 1995 |
| Received | Mar 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941350
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2003 | Wilson-Cook Medical Inc Spiral Z Expandable Metal Biliary Stent Terminated |
FGE | None listed |
| Aug 26, 2003 | Wilson-Cook Medical Inc Za-Stent Expandable Metal Biliary Stent Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.