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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 K150616
Device Name Trevo XP ProVue Retriever (4x30mm)
Applicant
Concentric Medical, Inc.
301 E. Evelyn Ave.
Mountain View,  CA  94041
Applicant Contact Rhoda M. Santos
Correspondent
Concentric Medical, Inc.
301 E. Evelyn Ave.
Mountain View,  CA  94041
Correspondent Contact Rhoda M. Santos
Regulation Number870.1250
Classification Product Code
NRY  
Date Received03/10/2015
Decision Date 06/12/2015
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
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