510(k) K162404 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Express SD Biliary Monorail Premounted Stent System
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 12, 2016 |
| Received | Aug 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162404
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.