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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 K182101
Device Name Riptide Aspiration System (React 71 Catheter)
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact Ryan Kenney
Correspondent
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Correspondent Contact Ryan Kenney
Regulation Number870.1250
Classification Product Code
NRY  
Date Received08/03/2018
Decision Date 11/14/2018
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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