510(k) K993904 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
INTRASTENT DOUBLESTRUT LD
| Applicant | Intratherapeutics, Inc., Saint Paul MN, US |
| Decision | Unknown, Feb 1, 2000 |
| Received | Nov 17, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993904
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2006 | Ev3, Inc IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expanda Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.