MARK V

Injector And Syringe, Angiographic

MEDRAD, INC.

The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Mark V.

Pre-market Notification Details

• Device ID: K822536
• 510k Number: K822536
• Device Name: MARK V
• Classification: Injector And Syringe, Angiographic
• Applicant: MEDRAD, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: DXT
• CFR Regulation Number: 870.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-08-24
• Decision Date: 1982-09-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40616258011002	K822536	000
40616258009931	K822536	000
40616258024347	K822536	000
40616258024330	K822536	000