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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 K233205
Device Name Distal Access Catheter
Applicant
Shanghai HeartCare Medical Technology Co.,Ltd.
590 Ruiqing Rd, Building 4, Suite 201,
East Zhangjiang High-Tech Park
Shanghai,  CN 201201
Applicant Contact Tianrong Hong
Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received09/28/2023
Decision Date 12/22/2023
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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