510(k) K153088 ยท PCU Pancreatic Stent, Covered, Metallic, Removable
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Dec 11, 2015 |
| Received | Oct 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153088
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.