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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 K120495
Device Name IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
Original Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311
Original Contact yumi wackerfuss
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/17/2012
Decision Date 05/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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