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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 K120893
Model M001314, M001315, M001316
Device Name IMAGER II ANGIOGRAPHIC CATHETERS
Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311
Contact anne v rossi
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/23/2012
Decision Date 03/29/2012
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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