510(k) K012822 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
| Applicant | Boston Scientific Scimed, Inc., Maple Grove MN, US |
| Decision | Unknown, Oct 24, 2001 |
| Received | Aug 23, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012822
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.