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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K001926
Device Name VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES
Applicant
THORATEC LABORATORIES CORP.
6035 STONERIDGE DR.
PLEASANTON,,  CA  94588
Applicant Contact DONALD A MIDDLEBROOK
Correspondent
THORATEC LABORATORIES CORP.
6035 STONERIDGE DR.
PLEASANTON,,  CA  94588
Correspondent Contact DONALD A MIDDLEBROOK
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/26/2000
Decision Date 09/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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