510(k) K913682 ยท DQO Catheter, Intravascular, Diagnostic
MERIT CUSTOM KIT
| Applicant | Merit Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 15, 1991 |
| Received | Aug 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913682
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | None listed |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872P, Revision H, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | None listed |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09304, Revision B, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | None listed |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | None listed |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision B, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | None listed |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | None listed |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Manufactured by Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | None listed |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12" STERILE K10-04129, CATALOG NUMBER K10-04129 Connection tubing can be used with any drainage catheter and drainag Terminated |
DQO | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/ STOPCOCK 12" CATALOG NUMBER K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and d Terminated |
DQO | None listed |
| Jan 13, 2009 | Merit Medical Systems, Inc. Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Terminated |
DQO | None listed |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | None listed |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | None listed |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | None listed |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | None listed |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | None listed |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit. Terminated |
DQO | None listed |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit Terminated |
DQO | None listed |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.