510(k) K212582 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
SpyGlass Discover Balloon Dilation Catheter
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, May 6, 2022 |
| Received | Aug 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212582
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.