510(k) K112701 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
CHARGER BALLOON DILATATION CATHETER
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 25, 2011 |
| Received | Sep 16, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112701
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.