Urethral dilatation catheter, drug-eluting

A urethral dilatation catheter, drug-eluting is a sterile, flexible tube designed to be inserted into the urethra to widen a narrowed or irregular passage. It features an inflatable balloon that dilates the urethra while releasing a drug, such as a chemotherapy agent, directly at the site of treatment to reduce recurrence or scarring.

This category includes only single-use devices, meaning each catheter is intended for one procedure and then discarded. Regulatory oversight focuses on the combined function of mechanical dilation and localized drug delivery, with classification determined by jurisdiction based on the device’s overall risk profile and intended use.