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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K191680
Device Name AZUR Vascular Plug
Applicant
MicroVention, Inc.
35 Enterprise
Aliso Veijo,  CA  92656
Applicant Contact Ganesh Balachander
Correspondent
MicroVention, Inc.
35 Enterprise
Aliso Veijo,  CA  92656
Correspondent Contact Ganesh Balachander
Regulation Number870.3300
Classification Product Code
KRD  
Date Received06/24/2019
Decision Date 03/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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