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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 K212288
Device Name Minjie Catheter System
Applicant
Kai Medtech, LLC
22651 Lambert St., Suite 107
Lake Forest,  CA  92630
Applicant Contact Stephanie Rallis
Correspondent
Kai Medtech, LLC
22651 Lambert St., Suite 107
Lake Forest,  CA  92630
Correspondent Contact Ricardo Olivo
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received07/21/2021
Decision Date 06/02/2022
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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