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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 K183185
Device Name Riptide Aspiration System (Riptide Large Bore Aspiration System)
Applicant
Micro Therapeutics Inc., d/b/a ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Applicant Contact Nancy Drew
Correspondent
Micro Therapeutics Inc., d/b/a ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Correspondent Contact Nancy Drew
Regulation Number870.1250
Classification Product Code
NRY  
Date Received11/19/2018
Decision Date 12/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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