510(k) K172044 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Sten
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Substantially Equivalent, Feb 27, 2018 |
| Received | Jul 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172044
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.