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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
Recalls CDRH Recalls
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