510(k) K163169 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Unknown, Feb 7, 2017 |
| Received | Nov 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163169
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.