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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 K203432
Device Name Axium Detachable Coil; Axium Prime Detachable Coil
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
5290 California Ave
Irvine,  CA  92617
Applicant Contact Bhavika Patel
Correspondent
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
5290 California Ave
Irvine,  CA  92617
Correspondent Contact Bhavika Patel
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received11/23/2020
Decision Date 07/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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