Device typeUrethral dilatation catheter, drug-eluting: A sterile, flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage; it includes a drug (e.g., chemotherapy drug) intended to be eluted in situ. The device is typically designed with an inflatable dilation balloon. This is a single-use device.
FDA categoryDrug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
Device ID00853095008235
Catalog number1189-30035
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Balloon Diameter30 Millimeter
Balloon Length35 Millimeter
Balloon Rated Burst Pressure4 Atmosphere