510(k) K213946 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Compass BDS Biliary Stent
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Substantially Equivalent, May 9, 2022 |
| Received | Dec 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213946
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.