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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K151447
Device Name Axium Detachable Coil System
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact PATRICIA CASING
Correspondent
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Correspondent Contact PATRICIA CASING
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received05/29/2015
Decision Date 07/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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