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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 K211021
Device Name Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
Applicant
Micro-Tech (Nanjing) Co., Ltd.
# 10 Goake Third Rd., Nanjig National Hi-Tech Industrial
Development Zone
Narijing,  CN 210032
Applicant Contact Cecilia Sun
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
# 10 Goake Third Rd., Nanjig National Hi-Tech Industrial
Development Zone
Narijing,  CN 210032
Correspondent Contact Becky Li
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/05/2021
Decision Date 05/06/2022
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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