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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 K201706
Device Name KDL Micro catheter
Applicant
Shanghai Kindly Medical Instruments Co.,Ltd
#925, Jinyuan Yi Rd.
Shanghai,  CN 201803
Applicant Contact Xu Jianhai
Correspondent
Shanghai Kindly Medical Instruments Co.,Ltd
#925, Jinyuan Yi Rd.
Shanghai,  CN 201803
Correspondent Contact Xu Jianhai
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/22/2020
Decision Date 07/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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