MODIFICATION TO FOUNTAIN INFUSION SYSTEM

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 Modification To Fountain Infusion System.

Pre-market Notification Details

• Device ID: K992231
• 510k Number: K992231
• Device Name: MODIFICATION TO FOUNTAIN INFUSION SYSTEM
• Classification: Catheter, Continuous Flush
• Applicant: MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095
• Contact: Chester Mccoy
• Correspondent: Chester Mccoy; 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-07-02
• Decision Date: 1999-07-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884450117429	K992231	000
10884450000851	K992231	000
10884450000868	K992231	000
10884450000875	K992231	000
10884450000882	K992231	000
10884450000899	K992231	000
10884450009991	K992231	000
10884450019372	K992231	000
10884450019389	K992231	000
10884450019396	K992231	000
10884450075415	K992231	000
10884450000806	K992231	000