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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 K121694
Model M001131XXXX
Device Name IMAGER II ANGIOGRAPHIC CATHETER
Original Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311 1566
Original Contact holly ramirez
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/07/2012
Decision Date 09/14/2012
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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