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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K222663
Device Name MultiStage Balloon Dilatation Catheter
Applicant
Dongguan TT Medical, Inc.
Bld#1, 1 Taoyuan Rd., Songshan Lake
Dongguan,  CN 523808
Applicant Contact Yuying Bi
Correspondent
Zi-medical, Inc.
93 Springs Rd.
Bedford,  MA  01730
Correspondent Contact Mingzi Hussey
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/02/2022
Decision Date 03/09/2023
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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