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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K141124
Device Name SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
Applicant
Vascular Flow Technologies, Ltd.
Prospect Business Centre
Gemini Cresent, Dundee Technology Park
Dundee,  GB DD2 1TY
Applicant Contact EDWIN LINDSAY
Correspondent
Vascular Flow Technologies, Ltd.
Prospect Business Centre
Gemini Cresent, Dundee Technology Park
Dundee,  GB DD2 1TY
Correspondent Contact EDWIN LINDSAY
Regulation Number870.3450
Classification Product Code
DSY  
Date Received05/01/2014
Decision Date 05/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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