510(k) K251291 · FGE Stents, Drains And Dilators For The Biliary Ducts
Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
| Applicant | Boston Scientific, Marborough MA, US |
| Decision | Substantially Equivalent, Jul 3, 2025 |
| Received | Apr 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251291
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.