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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K151396
Device Name MIVI Mi-AXUS Guide Catheter
Applicant
Mivi Neuroscience, Inc.
6545 City W. Pkwy.
Eden Prarie,  MN  55344
Applicant Contact Matthew Ogle
Correspondent
Novaqual
180s. 600w. Logan, Ut 84321
Logan,  UT  84321
Correspondent Contact Randy LaBounty
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/26/2015
Decision Date 12/09/2015
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
Recalls CDRH Recalls
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