510(k) K915678 ยท FPA Set, Administration, Intravascular
MERIT ADMINISTRATION SET
| Applicant | Merit Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 30, 1992 |
| Received | Dec 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915678
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2016 | Merit Medical Systems, Inc. Custom Fluid Management Set, Sterile, EO, Rx Only
Used to transfer contrast media and saline from a container to a patients
vascular system. Terminated |
FPA | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-05971AP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contras Terminated |
FPA | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-09051P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contras Terminated |
FPA | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-01280JP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | None listed |
| May 31, 2007 | Merit Medical Systems, Inc. Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMG | None listed |
| May 31, 2007 | Merit Medical Systems, Inc. Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000. Terminated |
FMG | None listed |
| May 31, 2007 | Merit Medical Systems, Inc. Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMG | None listed |
| May 31, 2007 | Merit Medical Systems, Inc. Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP, Merit Medical Systems, South Jordan, Utah. Terminated |
FMG | None listed |
| May 31, 2007 | Merit Medical Systems, Inc. Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah. Terminated |
FMG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.