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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K953114
Device Name EVOLUTION MICROCATHETER
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific pl.
natick,  MA  01760 1537
Original Contact mary p legraw
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/03/1995
Decision Date 09/12/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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