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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 K243080
Device Name Riptide Aspiration System
Applicant
Micro Therapeutics Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact Tony Rizzardi
Correspondent
Micro Therapeutics Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Correspondent Contact Tony Rizzardi
Regulation Number870.1250
Classification Product Code
NRY  
Date Received09/30/2024
Decision Date 10/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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