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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 K253832
Device Name Dilation Balloon Catheter
Applicant
Mirco-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd., Nanjing National Hi-Tech Industrial
Development Zone
Nanjing,  CN 210032
Applicant Contact Sally He
Correspondent
Mirco-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd., Nanjing National Hi-Tech Industrial
Development Zone
Nanjing,  CN 210032
Correspondent Contact Sally He
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/01/2025
Decision Date 04/24/2026
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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