510(k) K203162 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Advanix Biliary Stent with NaviFlex RX Delivery System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Dec 18, 2020 |
| Received | Oct 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203162
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.