510(k) K151925 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Elation Wireguided Balloon Dilation Catheter
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Nov 6, 2015 |
| Received | Jul 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151925
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.