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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(k) Number K232752
Device Name Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
Applicant
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
#52, Guoxiang Rd., Wujin Economic
Development Zone
Changzhou,  CN 213149
Applicant Contact Zheng Xinxing
Correspondent
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
#52, Guoxiang Rd., Wujin Economic
Development Zone
Changzhou,  CN 213149
Correspondent Contact Zheng Xinxing
Regulation Number876.5010
Classification Product Code
GCA  
Date Received09/08/2023
Decision Date 02/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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