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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 K163233
Device Name MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter
Applicant
MIVI NEUROSCIENCE, INC
6545 City West Parkway
Eden Prairie,  MN  55344
Applicant Contact Randy LaBounty
Correspondent
PHILBROOK CORPORATION
8701 E. VISTA BONITA DR., SUITE 210
Scottsdale,  AZ  85255
Correspondent Contact Avi Roop
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/17/2016
Decision Date 04/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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