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 Expanse Medical, Inc..
FDA 510(k) Cleared Aspiration Thrombectomy Catheter Devices (Product Code QEZ)
About Product Code QEZ - Regulatory Context
510(k) Submission Activity
92 total 510(k) submissions under product code QEZ since 1999, with 92 receiving FDA clearance (average review time: 107 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for QEZ submissions have been consistent, averaging 106 days recently vs 107 days historically.
QEZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →