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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 K192558
Device Name Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
Applicant
Mivi Neurovascular
6545 City W. Pkwy.
Eden Prarie,  MN  55344
Applicant Contact Janel Hurtado
Correspondent
Mivi Neurovascular
6545 City W. Pkwy.
Eden Prarie,  MN  55344
Correspondent Contact Janel Hurtado
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/17/2019
Decision Date 04/06/2020
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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