Device Dossier

Embolectomy/thrombectomy suction catheter

Device Dossier for Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class IIa, sponsor Boston Scientific). ARTG…

Intended purpose

A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, and/or in native and/or synthetic bypass and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of a syringe(s) attached to the proximal end of the catheter. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.

TGA Public Summary