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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 K222948
Device Name Q Distal Access Catheter
Applicant
MIVI Neuroscience, Inc
6545 City West Parkway
Eden Prairie,  MN  55344
Applicant Contact Srija Reddy Bandari
Correspondent
MIVI Neuroscience, Inc
6545 City West Parkway
Eden Prairie,  MN  55344
Correspondent Contact Srija Reddy Bandari
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received09/27/2022
Decision Date 09/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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