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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 K910865
Device Name TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
Applicant
Vascutek, Ltd.
Newmains Ave.
Inchinnan Renfrewshire
Pa49rr Scotland,  GB
Applicant Contact ROSHAN MAINI
Correspondent
Vascutek, Ltd.
Newmains Ave.
Inchinnan Renfrewshire
Pa49rr Scotland,  GB
Correspondent Contact ROSHAN MAINI
Regulation Number870.3450
Classification Product Code
DSY  
Date Received03/01/1991
Decision Date 04/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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