510(k) K001338 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Aug 30, 2000 |
| Received | Apr 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001338
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.