MONARCH INFLATION SYRINGE; UNIVERSAL 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 Monarch Inflation Syringe; Universal Fluid Dispensing Syringe.

Pre-market Notification Details

• Device ID: K011811
• 510k Number: K011811
• Device Name: MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE
• Classification: Injector And Syringe, Angiographic
• Applicant: MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095
• Contact: Dan Reigle
• Correspondent: Dan Reigle; MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095
• Product Code: DXT
• CFR Regulation Number: 870.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-06-11
• Decision Date: 2001-08-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994686374	K011811	000
00643169097162	K011811	000
00858196001079	K011811	000