69 devices · GMDN 61205
A mechanical atherectomy system for coronary use is a line-powered assembly designed to physically remove atherosclerotic plaque from coronary artery walls. It consists of an AC-powered generator with monitoring capabilities, a control interface such as a foot-switch or remote, a handpiece, and a disposable catheter featuring a cutting or abrasive tip that delivers mechanical energy to the lesion. The system may also incorporate irrigation and suction functions and requires accessories like saline, lubricant, or guidewires to operate effectively.
Devices in this category are regulated as active medical devices that rely on mains electricity for operation and are intended for use in percutaneous coronary interventions. They are supplied as systems comprising reusable capital equipment and single-use disposable components, with the catheter typically being discarded after each procedure. Regulatory oversight focuses on the safety and performance of the system as a whole, including its energy delivery, control mechanisms, and associated accessories.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.