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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 K120961
Device Name TREVO RETRIEVER
Applicant
CONCENTRIC MEDICAL, INC.
301 E Evelyn Ave
MOUNTAIN VIEW,  CA  94041
Applicant Contact KIRSTEN VALLEY
Correspondent
CONCENTRIC MEDICAL, INC.
301 E Evelyn Ave
MOUNTAIN VIEW,  CA  94041
Correspondent Contact KIRSTEN VALLEY
Regulation Number870.1250
Classification Product Code
NRY  
Date Received03/30/2012
Decision Date 08/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT01270867
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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