HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES

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 Hemapatch Vascular Patches, Intergard And Intergard-rs Vascular Prostheses.

Pre-market Notification Details

• Device ID: K964625
• 510k Number: K964625
• Device Name: HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
• 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: Se Subject To Tracking Reg (ST)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-11-15
• Decision Date: 1997-05-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00384401014096	K964625	000
00384401001560	K964625	000
00384401001522	K964625	000
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00384401014317	K964625	000
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00384401014287	K964625	000
00384401014270	K964625	000
00384401014102	K964625	000