DiamondTOUCH Inflation Device And Fluid Dispensing Syringe

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 Diamondtouch Inflation Device And Fluid Dispensing Syringe.

Pre-market Notification Details

• Device ID: K160107
• 510k Number: K160107
• Device Name: DiamondTOUCH Inflation Device And Fluid Dispensing Syringe
• Classification: Injector And Syringe, Angiographic
• Applicant: Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
• Contact: Dan W Lindsay
• Correspondent: Dan W Lindsay; Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
• Product Code: DXT
• CFR Regulation Number: 870.1650 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-01-19
• Decision Date: 2016-07-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884450324810	K160107	000
20884450324800	K160107	000
10884450324780	K160107	000
20884450264908	K160107	000
10884450409654	K160107	000