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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
Device Name MODIFIED TREVO RETRIEVER
Applicant
CONCENTRIC MEDICAL, INC.
301 E Evelyn Ave
MOUNTAIN VIEW,  CA  94041
Applicant Contact CHRISTINA ROWE
Correspondent
CONCENTRIC MEDICAL, INC.
301 E Evelyn Ave
MOUNTAIN VIEW,  CA  94041
Correspondent Contact CHRISTINA ROWE
Regulation Number870.1250
Classification Product Code
NRY  
Date Received08/14/2012
Decision Date 10/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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