Device typeGastrointestinal/biliary dilation balloon catheter, non-medicated: A 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.
FDA categoryStents, drains and dilators for the biliary ducts
Device ID00884450399354
Catalog numberEPB6/A
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
SizeBalloon Outer Diameters-6 mm, 7 mm, 8 mm
SizeCatheter Length-180 cm
SizeBalloon Length-5.5 cm
SizeBalloon Length-5.5 cm; Balloon Outer Diameters-6 mm, 7 mm, 8 mm; Catheter Length-180 cm; Balloon Length-5.5 cm
SizeCatheter Length-180 cm; Balloon Outer Diameters-6 mm, 7 mm, 8 mm; Catheter Length-180 cm; Balloon Length-5.5 cm