510(k) K011909 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ULTRA-THIN SDS BALLOON DILATATION CATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Nov 28, 2001 |
| Received | Jun 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011909
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.