510(k) K063733 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
RESOLVE BILIARY DRAINAGE CATHETER
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Nov 14, 2007 |
| Received | Dec 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063733
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Merit Medical Systems, Inc. ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Used for drainage of bile within the biliary system. Terminated |
FGE | None listed |
| Jan 13, 2009 | Merit Medical Systems, Inc. ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095
Used for drainage of bile within the biliary system. Terminated |
FGE | None listed |
| Jan 13, 2009 | Merit Medical Systems, Inc. ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system. Terminated |
FGE | None listed |
| Jan 13, 2009 | Merit Medical Systems, Inc. ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. 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.