510(k) K172057 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Substantially Equivalent, Mar 9, 2018 |
| Received | Jul 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172057
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.