Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / Short-wire Compatible

Stents, Drains And Dilators For The Biliary Ducts

Micro-Tech (Nanjing) Co., Ltd.

The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / Short-wire Compatible.

Pre-market Notification Details

Device IDK211021
510k NumberK211021
Device Name:Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / Short-wire Compatible
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant Micro-Tech (Nanjing) Co., Ltd. No. 10 Goake Third Road, Nanjig National Hi-Tech Industrial Development Zone Narijing,  CN 210032
ContactCecilia Sun
CorrespondentBecky Li
Micro-Tech (Nanjing) Co., Ltd. No. 10 Goake Third Road, Nanjig National Hi-Tech Industrial Development Zone Narijing,  CN 210032
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-05
Decision Date2022-05-06

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