3f4ad9da-b6d6-4e1f-9835-776607a3de00NewPublished12026-04-222026-04-14In Commercial Distribution26970057571021PackageGS1069700575710272In Commercial Distributionbox06970057571027PrimaryGS156970057571022PackageGS10697005757102720In Commercial DistributioncartonStone Extraction BalloonVDK-BAL-23-11/13/15-B544430136Jiangsu Vedkang Medical Science and Technology Co.,Ltd.1falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK23275200046715ERCP catheter, balloon, non-electrical, stone-retrievalA flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.falseActiveGCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injectiontruefalse