INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

INTERVASCULAR, INC.

The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Intergard Knitted Ultra Thin Collagen Coated Vascular Graft And Hemacarotid Patch Ultra Thin.

Pre-market Notification Details

• Device ID: K983819
• 510k Number: K983819
• Device Name: INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
• Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Applicant: INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130
• Contact: James S Miller
• Correspondent: James S Miller; INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130
• Product Code: DSY
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-10-29
• Decision Date: 1998-11-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00384401006466	K983819	000
00384401001270	K983819	000
00384401001294	K983819	000
00384401001362	K983819	000
00384401001379	K983819	000
00384401001461	K983819	000
00384401001478	K983819	000
00384401001485	K983819	000
00384401001492	K983819	000
00384401001508	K983819	000
00384401010708	K983819	000
00384401010715	K983819	000
00384401001263	K983819	000
00384401001225	K983819	000
00384401007067	K983819	000
00384401007609	K983819	000
00384401009252	K983819	000
00384401011224	K983819	000
00384401011248	K983819	000
00384401001157	K983819	000
00384401001164	K983819	000
00384401001171	K983819	000
00384401001195	K983819	000
00384401001201	K983819	000
00384401001218	K983819	000
00384401014034	K983819	000
00384401014669	K983819	000
00384401014676	K983819	000
00384401014928	K983819	000
00384401014935	K983819	000
00384401014942	K983819	000
00384401014959	K983819	000
00384401014966	K983819	000
00384401014973	K983819	000
00384401014980	K983819	000
00384401015147	K983819	000
00384401015154	K983819	000
00384401015161	K983819	000
00384401015192	K983819	000
00384401014805	K983819	000
00384401014799	K983819	000
00384401014683	K983819	000
00384401014690	K983819	000
00384401014706	K983819	000
00384401014713	K983819	000
00384401014720	K983819	000
00384401014737	K983819	000
00384401014744	K983819	000
00384401014751	K983819	000
00384401014768	K983819	000
00384401014775	K983819	000
00384401014782	K983819	000
00384401015208	K983819	000