510(k) K910006 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
AVD INTIMAX (TM) BILIARY CATHETER
| Applicant | Applied Vascular, Launa Hills CA, US |
| Decision | Substantially Equivalent, Feb 13, 1991 |
| Received | Jan 2, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2012 | Applied Medical Resources Corp Biliary Catheters (Models A47XX and CB0XXXXX):
Model Numbers & Description:
A4752, SYNTEL BILIARY 5F-23CM CATHETER;
A4754, SYNTEL BILIARY 5F-40CM CATHETER;
A4762, SYNTEL BILIARY 6F-23CM CATHETER;
CB0 Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.