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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
Original Applicant
THORATEC LABORATORIES CORP.
6035 stoneridge dr.
pleasanton,,  CA  94588
Original Contact donald a middlebrook
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/26/2000
Decision Date 09/22/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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