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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
510(k) Number K173352
Device Name Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
Applicant
Concentric Medical, Inc.
301 East Evelyn Avenue
Mountain View,  CA  94041
Applicant Contact Rhoda M. Santos
Correspondent
Concentric Medical, Inc.
301 East Evelyn Avenue
Mountain View,  CA  94041
Correspondent Contact Rhoda M. Santos
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received10/25/2017
Decision Date 02/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02142283
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Recalls CDRH Recalls
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