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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 K122581
Model 90253, 90254
Device Name MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
Original Applicant
CONCENTRIC MEDICAL, INC.
301 e evelyn ave
mountain view,  CA  94041
Original Contact christina rowe
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/23/2012
Decision Date 11/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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