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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K151825
Device Name Viradius Neurowire
Applicant
Mivi Neuroscience, Inc.
6545 City W. Pkwy.
Eden Prarie,  MN  55344
Applicant Contact RANDY LABOUNTY
Correspondent
Mivi Neuroscience, Inc.
6545 City W. Pkwy.
Eden Prarie,  MN  55344
Correspondent Contact RANDY LABOUNTY
Regulation Number870.1330
Classification Product Code
MOF  
Date Received07/06/2015
Decision Date 11/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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