CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

INTERVASCULAR, SAS

The following data is part of a premarket notification filed by Intervascular, Sas with the FDA for Cardioroot Woven Collagen Coated Vascular Prostheses.

Pre-market Notification Details

• Device ID: K103347
• 510k Number: K103347
• Device Name: CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
• Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Applicant: INTERVASCULAR, SAS ZONE INDUSTRIELLE ATHELIA I Laciotat, FR 13705
• Contact: Philippe Bensimon
• Correspondent: Philippe Bensimon; INTERVASCULAR, SAS ZONE INDUSTRIELLE ATHELIA I Laciotat, FR 13705
• Product Code: DSY
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-15
• Decision Date: 2011-02-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00384401013938	K103347	000
00384401013921	K103347	000
00384401013914	K103347	000
00384401013907	K103347	000
00384401013891	K103347	000
00384401013884	K103347	000