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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 K001927
Device Name VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
Applicant
Thoratec Laboratories Corp.
6035 Stoneridge Dr.
Pleasnaton,  CA  94588
Applicant Contact DONALD A MIDDLEBROOK
Correspondent
Thoratec Laboratories Corp.
6035 Stoneridge Dr.
Pleasnaton,  CA  94588
Correspondent Contact DONALD A MIDDLEBROOK
Regulation Number870.3450
Classification Product Code
DSY  
Subsequent Product Code
DYF  
Date Received06/26/2000
Decision Date 12/18/2000
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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