FDA Product Code QEZ: Aspiration Thrombectomy Catheter

Aspiration thrombectomy removes clot by suction rather than mechanical fragmentation. FDA product code QEZ covers aspiration thrombectomy catheters for coronary and peripheral use.

These large-bore catheters are connected to a suction source and advanced to the clot to directly aspirate thrombus from occluded vessels. They are used in acute myocardial infarction and peripheral arterial occlusion to reduce thrombus burden before or after balloon angioplasty.

QEZ devices are Class II medical devices, regulated under 21 CFR 870.5150 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Possis Medical, Inc., Vascular Solutions, Inc. and Walk Vascular, LLC.