MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM

Injector And Syringe, Angiographic

MEDRAD, INC.

The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Avanta Fluid Management Injection System.

Pre-market Notification Details

• Device ID: K050456
• 510k Number: K050456
• Device Name: MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
• Classification: Injector And Syringe, Angiographic
• Applicant: MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051
• Contact: Geoff M Fatzinger
• Correspondent: Geoff M Fatzinger; MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051
• Product Code: DXT
• CFR Regulation Number: 870.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-02-23
• Decision Date: 2005-06-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40616258024361	K050456	000
00616258025773	K050456	000
00616258010373	K050456	000
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10616258007530	K050456	000
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40616258010852	K050456	000