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
40616258024439	K023183	000
40616258022206	K023183	000
40616258022220	K023183	000
40616258009917	K023183	000
40616258009962	K023183	000
10616258005178	K023183	000
10616258005185	K023183	000
10616258005208	K023183	000
10616258005215	K023183	000
10616258005222	K023183	000
10616258005239	K023183	000
10616258005253	K023183	000
10616258005260	K023183	000
10616258005277	K023183	000
40616258022183	K023183	000
40616258022169	K023183	000
40616258022138	K023183	000
40616258024583	K023183	000
40616258024590	K023183	000
40616258024606	K023183	000
40616258024620	K023183	000
40616258024637	K023183	000
40616258024644	K023183	000
40616258024651	K023183	000
00616258020662	K023183	000
40616258021902	K023183	000
40616258021926	K023183	000
40616258021933	K023183	000
40616258022084	K023183	000
40616258022121	K023183	000
10616258007035	K023183	000
10616258007042	K023183	000
00616258007151	K023183	000
00616258008967	K023183	000
00616258008974	K023183	000
00616258008981	K023183	000
40616258009894	K023183	000
40616258009900	K023183	000
40616258009979	K023183	000
40616258009986	K023183	000
00616258010243	K023183	000
00616258010250	K023183	000
00616258010571	K023183	000
00616258010588	K023183	000
40616258010920	K023183	000
40616258010937	K023183	000
00616258008950	K023183	000
00616258008912	K023183	000
00616258008905	K023183	000
10616258007165	K023183	000
10616258007400	K023183	000
10616258007448	K023183	000
10616258007455	K023183	000
00616258007465	K023183	000
10616258007929	K023183	000
10616258007936	K023183	000
10616258007943	K023183	000
10616258007950	K023183	000
10616258007974	K023183	000
00616258008875	K023183	000
00616258008882	K023183	000
00616258008899	K023183	000
00616258021348	K023183	000