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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K182097
Device Name 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
DQY  
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
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