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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K222679
Device Name Vericor Support Catheter
Applicant
VascuPatent Medical (Shenzhen) Co. Ltd.
Room 314&316, Building A, Branch 3,
Leibai Zhongcheng Life Science Park,No.22 Jinxiu East Road
Shenzhen,  CN 518122
Applicant Contact Heather Li
Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1210
Classification Product Code
KRA  
Date Received09/06/2022
Decision Date 11/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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