MERIT ADMINISTRATION SET

Set, Administration, Intravascular

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Administration Set.

Pre-market Notification Details

• Device ID: K915678
• 510k Number: K915678
• Device Name: MERIT ADMINISTRATION SET
• Classification: Set, Administration, Intravascular
• Applicant: MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107
• Contact: Dennis Reigle
• Correspondent: Dennis Reigle; MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-12-19
• Decision Date: 1992-07-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884450262822	K915678	000
10884450024253	K915678	000
20884450022621	K915678	000
10884450022341	K915678	000
10884450021399	K915678	000
10884450021238	K915678	000
10884450019259	K915678	000
20884450019225	K915678	000
20884450010550	K915678	000
10884450008024	K915678	000
10884450007775	K915678	000
10889942365043	K915678	000
10889942363940	K915678	000
10884450025458	K915678	000
20884450027701	K915678	000
10884450028763	K915678	000
20884450122116	K915678	000
10884450115111	K915678	000
20884450110670	K915678	000
20884450107601	K915678	000
20884450107410	K915678	000
10884450106997	K915678	000
10884450104498	K915678	000
20884450056428	K915678	000
20884450029767	K915678	000
20884450029743	K915678	000
20884450029156	K915678	000
20884450029132	K915678	000
10884450095901	K915678	000