MERIT MICROCATHETER

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 Merit Microcatheter.

Pre-market Notification Details

• Device ID: K082613
• 510k Number: K082613
• Device Name: MERIT MICROCATHETER
• Classification: Catheter, Continuous Flush
• Applicant: MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095
• Contact: Michaela Rivkowich
• Correspondent: Michaela Rivkowich; 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: 2008-09-08
• Decision Date: 2008-12-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884450358092	K082613	000
10884450038465	K082613	000
10884450038458	K082613	000
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