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 categoryDilator, esophageal
Device ID20653405052446
Catalog number000343
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information
Size2.8 Millimeter
Pressure90 Pound per Square Inch
Outer Diameter12 Centimeter
Catheter Gauge36 French
Pressure6200 millibar
Length8 Millimeter