Stone Retrieval Balloon

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Hangzhou AGS MedTech Co., Ltd.

The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd. with the FDA for Stone Retrieval Balloon.

Pre-market Notification Details

Device IDK200173
510k NumberK200173
Device Name:Stone Retrieval Balloon
ClassificationBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Applicant Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou,  CN 311106
ContactChunqi Han
CorrespondentChunqi Han
Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou,  CN 311106
Product CodeGCA  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-23
Decision Date2020-05-01

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