GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

VASCUTEK LTD.

The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Gelweave Ante-flo With Collar And Gelweave 4 Branch Plexus With Collar.

Pre-market Notification Details

• Device ID: K040829
• 510k Number: K040829
• Device Name: GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
• Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Applicant: VASCUTEK LTD. 6200 JACKSON RD. Ann Arbor, MI 48103 -9300
• Contact: Steven Arick
• Correspondent: Steven Arick; VASCUTEK LTD. 6200 JACKSON RD. Ann Arbor, MI 48103 -9300
• Product Code: DSY
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-03-31
• Decision Date: 2004-05-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05037881105963	K040829	000
05037881017938	K040829	000
05037881017921	K040829	000
05037881017914	K040829	000
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05037881105918	K040829	000
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05037881010953	K040829	000
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05037881105994	K040829	000