MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI

Wire, Guide, Catheter

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Meri-dapt(tm) Hemostasis Valve/torqloc Torque Devi.

Pre-market Notification Details

• Device ID: K921702
• 510k Number: K921702
• Device Name: MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI
• Classification: Wire, Guide, Catheter
• Applicant: MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107
• Contact: Dennis Reigle
• Correspondent: Dennis Reigle; MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-04-10
• Decision Date: 1992-09-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884450028562	K921702	000
20884450013728	K921702	000