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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 K251019
Device Name BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
Applicant
Bioteque Corporation
5f-6, # 23, Sec.1, Chang’An E. Rd.,
Zhongshan Dist
Taipei,  TW 104
Applicant Contact Stella Hsu
Correspondent
Bioteque Corporation
5f-6, # 23, Sec.1, Chang’An E. Rd.,
Zhongshan Dist
Taipei,  TW 104
Correspondent Contact Stella Hsu
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Codes
GBO   LJE  
Date Received04/02/2025
Decision Date 12/22/2025
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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