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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
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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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