510(k) K192043 ยท PCU Pancreatic Stent, Covered, Metallic, Removable
AXIOS Stent and Electrocautery Enhanced Delivery System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Aug 26, 2019 |
| Received | Jul 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192043
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.