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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, thrombus retriever
510(k) Number K122478
Model 90184
Device Name MODIFIED TREVO RETRIEVER
Original Applicant
CONCENTRIC MEDICAL, INC.
301 e evelyn ave
mountain view,  CA  94041
Original Contact christina rowe
Regulation Number870.1250
Classification Product Code
NRY  
Date Received08/14/2012
Decision Date 10/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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