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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 K162226
Device Name Reliant Multistage Dilatation Balloon Catheter
Applicant
Micro-Tech (Nanjing) CO., Ltd.
NO. 10 Gaoke Third Road
Nanjing,  CN 210032
Applicant Contact Becky Li
Correspondent
Micro-Tech (Nanjing) CO., Ltd.
NO. 10 Gaoke Third Road
Nanjing,  CN 210032
Correspondent Contact Becky Li
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
KNQ  
Date Received08/08/2016
Decision Date 01/25/2017
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
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