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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 K143077
Device Name Trevo XP ProVue Retriever (6X25mm)
Applicant
CONCENTRIC MEDICAL, INC.
301 EAST EVELYN AVENUE
MOUNTAIN VIEW,  CA  94041
Applicant Contact Bill Hyatt
Correspondent
CONCENTRIC MEDICAL, INC.
301 EAST EVELYN AVENUE
MOUNTAIN VIEW,  CA  94041
Correspondent Contact Bill Hyatt
Regulation Number870.1250
Classification Product Code
NRY  
Date Received10/27/2014
Decision Date 04/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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