46567a77-0677-41e3-b436-fe9879a3aaacUpdatePublished32024-12-232016-09-24In Commercial Distribution08714729339366PrimaryGS1CRE WireguidedM00558430021717889BOSTON SCIENTIFIC CORPORATION1Esophageal/Pyloric Wireguided Balloon Dilatation CatheterfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse45712Gastrointestinal/biliary dilation balloon catheter, non-medicatedA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.falseActiveKNQDilator, esophagealFDFColonoscope and accessories, flexible/rigidFDTduodenoscope and accessories, flexible/rigidDevice Size Text, specify18 mm DiameterDevice Size Text, specify15 mm DiameterDevice Size Text, specify16.5 mm Diametertruefalse