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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, Neurovasculature
510(k) Number K212402
Device Name MIVI Q Distal Access Catheter
Applicant
Mivi Neuroscience, Inc.
6545 City W. Pkwy.
Eden Prairie,  MN  55443
Applicant Contact Janel Hurtado
Correspondent
Mivi Neuroscience, Inc.
6545 City W. Pkwy.
Eden Prairie,  MN  55443
Correspondent Contact Janel Hurtado
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received08/02/2021
Decision Date 12/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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