510(k) K220112 ยท PCU Pancreatic Stent, Covered, Metallic, Removable
AXIOS Stent and Electrocautery-Enhanced Delivery System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Sep 7, 2022 |
| Received | Jan 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220112
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.