510(k) K121832 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
| Applicant | Merit Medical Systems, Inc., Angleton TX, US |
| Decision | Substantially Equivalent, Jul 17, 2012 |
| Received | Jun 22, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121832
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2013 | Merit Medical Systems, Inc. Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.