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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K112404
Model 90072, 90073, 90074, 90076, 90077
Device Name CONCENTRIC BALLOON GUIDE CATHETER
Original Applicant
CONCENTRIC MEDICAL, INC.
301 e. evelyn ave.
mountain view,  CA  94041
Original Contact kirsten valley
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/22/2011
Decision Date 03/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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