510(k) K000864 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
INTRASTENT DOUBLESTRUT XS STENT
| Applicant | Intratherapeutics, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Apr 14, 2000 |
| Received | Mar 17, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000864
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.