DISPOSABLE CORONARY CONTROL SYRINGE 12CC

Injector And Syringe, Angiographic

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Disposable Coronary Control Syringe 12cc.

Pre-market Notification Details

• Device ID: K875196
• 510k Number: K875196
• Device Name: DISPOSABLE CORONARY CONTROL SYRINGE 12CC
• Classification: Injector And Syringe, Angiographic
• Applicant: MERIT MEDICAL SYSTEMS, INC. P.O. BOX 17484 Salt Lake City, UT 84117
• Contact: Fred Lampropoulos
• Correspondent: Fred Lampropoulos; MERIT MEDICAL SYSTEMS, INC. P.O. BOX 17484 Salt Lake City, UT 84117
• Product Code: DXT
• CFR Regulation Number: 870.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-12-17
• Decision Date: 1988-02-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884450021313	K875196	000
10884450011901	K875196	000
20884450011892	K875196	000
20884450011885	K875196	000
10884450011871	K875196	000
20884450011861	K875196	000
20884450011854	K875196	000
20884450011847	K875196	000
10884450011833	K875196	000
20884450011823	K875196	000
10884450011819	K875196	000
20884450011403	K875196	000
10884450011307	K875196	000
10884450011932	K875196	000
10884450011949	K875196	000
10884450021290	K875196	000
10884450021276	K875196	000
10884450021245	K875196	000
20884450019652	K875196	000
10884450019648	K875196	000
20884450019621	K875196	000
20884450019188	K875196	000
10884450013806	K875196	000
20884450013797	K875196	000
10884450012267	K875196	000
10884450012014	K875196	000
20884450011953	K875196	000
10884450008291	K875196	000
20884450007710	K875196	000
20884450006799	K875196	000
10884450006785	K875196	000
10884450006778	K875196	000
10884450006761	K875196	000
10884450006754	K875196	000
10889942335435	K875196	000
10193489739169	K875196	000
10193489858990	K875196	000
10193489850475	K875196	000
10884389291160	K875196	000
40193489739184	K875196	000
10193489739176	K875196	000
20884450006843	K875196	000
20884450007048	K875196	000
20884450007703	K875196	000
10884450007690	K875196	000
10884450007683	K875196	000
20884450007673	K875196	000
10884450007669	K875196	000
20884450007376	K875196	000
20884450007369	K875196	000
20884450007192	K875196	000
20884450007086	K875196	000
10884450007072	K875196	000
20884450007062	K875196	000
20884450007055	K875196	000
40193489739153	K875196	000
20884450121782	K875196	000
10884450103903	K875196	000
20884450102392	K875196	000
20884450101999	K875196	000
10884450101800	K875196	000
10884450099169	K875196	000
10884450095949	K875196	000
10884450085735	K875196	000
20884450081383	K875196	000
10884450076481	K875196	000
20884450076471	K875196	000
20884450075603	K875196	000
10884450056001	K875196	000
20884450104433	K875196	000
20884450109889	K875196	000
10884450121518	K875196	000
20884450120921	K875196	000
20884450120891	K875196	000
20884450120402	K875196	000
20884450119277	K875196	000
20884450117440	K875196	000
20884450117259	K875196	000
20884450117044	K875196	000
10884450114428	K875196	000
10884450114350	K875196	000
10884450112745	K875196	000
20884450109940	K875196	000
20884450055421	K875196	000
20884450053991	K875196	000
20884450025400	K875196	000
20884450024564	K875196	000
20884450024236	K875196	000
20884450023741	K875196	000
10884450023737	K875196	000
10884450023720	K875196	000
10884450023713	K875196	000
20884450023703	K875196	000
10884450022907	K875196	000
20884450022898	K875196	000
10884450022884	K875196	000
10884450022877	K875196	000
10884450025939	K875196	000
10884450025946	K875196	000
20884450052239	K875196	000
20884450050563	K875196	000
10884450050559	K875196	000
20884450050259	K875196	000
10884450030315	K875196	000
10884450029371	K875196	000
10884450029357	K875196	000
10884450027841	K875196	000
10884450027834	K875196	000
10884450027803	K875196	000
20884450027770	K875196	000
20884450027732	K875196	000
10884450021320	K875196	000