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 AngioDynamics, Inc., Abbott Medical and Merit Medical Systems, Inc..
List of Aspiration Thrombectomy Catheter devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Aspiration Thrombectomy Catheter devices (product code QEZ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →