FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE

Catheter, Continuous Flush

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Fountain Infusion Catheter And Occluding Guide Wire.

Pre-market Notification Details

• Device ID: K974067
• 510k Number: K974067
• Device Name: FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
• Classification: Catheter, Continuous Flush
• Applicant: MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095
• Contact: Dennis Reigle
• Correspondent: Dennis Reigle; MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095
• Product Code: KRA
• CFR Regulation Number: 870.1210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-10-27
• Decision Date: 1998-02-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884450000790	K974067	000
10884450012144	K974067	000
10884450012151	K974067	000
10884450012274	K974067	000
10884450013431	K974067	000
10884450013448	K974067	000
10884450019273	K974067	000
10884450019280	K974067	000
10884450019297	K974067	000
10884450019310	K974067	000
10884450019327	K974067	000
10884450019334	K974067	000
10884450019358	K974067	000
10884450022631	K974067	000
10884450012120	K974067	000
10884450012113	K974067	000
10884450012090	K974067	000
10884450011567	K974067	000
10884450011574	K974067	000
10884450011581	K974067	000
10884450011598	K974067	000
10884450011604	K974067	000
10884450011611	K974067	000
10884450011628	K974067	000
10884450011635	K974067	000
10884450011642	K974067	000
10884450011659	K974067	000
10884450011666	K974067	000
10884450011673	K974067	000
10884450012083	K974067	000
10884450022648	K974067	000
10884450022655	K974067	000
10884450025557	K974067	000
10884450025571	K974067	000
10884450025595	K974067	000
10884450029166	K974067	000
10884450029173	K974067	000
10884450029180	K974067	000
10884450029197	K974067	000
10884450029777	K974067	000
10884450029784	K974067	000
10884450029791	K974067	000
10884450029814	K974067	000
10884450029821	K974067	000
10884450029838	K974067	000
10884450025540	K974067	000
10884450025533	K974067	000
10884450025526	K974067	000
10884450022693	K974067	000
10884450023430	K974067	000
10884450023447	K974067	000
10884450023454	K974067	000
10884450023485	K974067	000
10884450023492	K974067	000
10884450023508	K974067	000
10884450025465	K974067	000
10884450025472	K974067	000
10884450025489	K974067	000
10884450025496	K974067	000
10884450025502	K974067	000
10884450025519	K974067	000
10884450029845	K974067	000