510(k) K935094 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
BALLOON DILATION CATHETER
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Jan 24, 1995 |
| Received | Oct 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935094
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2007 | Cook Endoscopy Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 Terminated |
KNQ | None listed |
| Oct 15, 2003 | Wilson-Cook Medical Inc Quantum TTC Biliary Balloon Dilator Terminated |
KNQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.