MEDRAD STELLANT CT INJECTOR 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 Stellant Ct Injector System.

Pre-market Notification Details

• Device ID: K023183
• 510k Number: K023183
• Device Name: MEDRAD STELLANT CT INJECTOR SYSTEM
• Classification: Injector And Syringe, Angiographic
• Applicant: MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051
• Contact: Frank W Pelc Iii
• Correspondent: Frank W Pelc Iii; MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051
• Product Code: DXT
• CFR Regulation Number: 870.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-09-24
• Decision Date: 2003-01-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00616258020662	K023183	000
10616258005208	K023183	000
10616258005215	K023183	000
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00616258007151	K023183	000
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10616258005185	K023183	000
10616258005178	K023183	000
40616258009962	K023183	000
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40616258022084	K023183	000
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00616258008981	K023183	000
40616258009894	K023183	000
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