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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 K060741
Device Name SWIRLGRAFT VASCULAR ACCESS GRAFT
Applicant
Veryan Medical Limited
1327 Bluegrass Way
Gambrills,  MD  21054
Applicant Contact SEMITH OKTAY
Correspondent
Veryan Medical Limited
1327 Bluegrass Way
Gambrills,  MD  21054
Correspondent Contact SEMITH OKTAY
Regulation Number870.3450
Classification Product Code
DSY  
Date Received03/20/2006
Decision Date 04/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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