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., Walk Vascular, LLC and Medtronic Vascular.
92
Total
92
Cleared
107d
Avg days
1999
Since
Growing category -
8 submissions in the last 2 years
vs 2 in the prior period
Consistent review times:
106d avg (recent)
FDA 510(k) Cleared Aspiration Thrombectomy Catheter Devices (Product Code QEZ)
92 devices
Cleared
Apr 23, 2026
Liberant™ RX Aspiration Catheter
Medtronic Interventional Vascular, Inc.
Cardiovascular
157d
Cleared
Mar 20, 2026
FLOWRUNNER Aspiration System
Expanse Medical, Inc.
Cardiovascular
81d
Cleared
Jan 15, 2026
Aventus Thrombectomy System
Inquis Medical
Cardiovascular
38d
Cleared
Nov 24, 2025
AlphaVac Multipurpose Mechanical Aspiration System F1885
AngioDynamics, Inc.
Cardiovascular
108d
Cleared
Oct 24, 2025
Vesalio Peripheral System
Vesalio, Inc.
Cardiovascular
179d
Cleared
Jul 14, 2025
FLOWRUNNER Aspiration System
Expanse Medical, Inc.
Cardiovascular
61d
Cleared
Apr 04, 2025
JETi Hydrodynamic Thrombectomy System
Abbott Medical
Cardiovascular
140d
Cleared
Mar 24, 2025
VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)
Control Medical Technology, Inc. / Dba Ventiv Scientific
Cardiovascular
81d
Cleared
Apr 01, 2024
AlphaVac MMA F1885 System (H787253020)
AngioDynamics, Inc.
Cardiovascular
52d
Cleared
Dec 19, 2023
JETi™Hydrodynamic Thrombectomy System
Abbott Medical
Cardiovascular
126d
Cleared
Apr 04, 2022
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
AngioDynamics, Inc.
Cardiovascular
172d
Cleared
Feb 01, 2022
JETi AIO Peripheral Thrombectomy System
Walk Vascular, LLC
Cardiovascular
84d
Cleared
Nov 03, 2021
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
Merit Medical Systems, Inc.
Cardiovascular
112d
Cleared
Oct 26, 2021
Thrombuster II Aspiration Catheter
Kaneka Medical America, LLC
Cardiovascular
28d
Cleared
Jun 04, 2021
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
AngioDynamics, Inc.
Cardiovascular
53d
Cleared
Nov 17, 2020
JETi AIO Peripheral Thrombectomy System
Walk Vascular, LLC
Cardiovascular
120d
Cleared
May 04, 2020
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
Control Medical Technology
Cardiovascular
33d
Cleared
Apr 20, 2020
QuickClear Mechanical Thrombectomy System
Volcano Atheromed, Inc.
Cardiovascular
152d
Cleared
Dec 09, 2019
JETi Peripheral Thrombectomy System
Walk Vascular, LLC
Cardiovascular
94d
Cleared
Apr 29, 2019
Aspiron(TM) Aspiration Catheter
Meril Life Sciences Private Limited
Cardiovascular
49d
Cleared
Apr 17, 2019
JETi 88 Peripheral Thrombectomy System
Walk Vascular, LLC
Cardiovascular
131d
Cleared
Sep 11, 2018
Octane Mechanical Thrombectomy System
Vascular Solutions, Inc.
Cardiovascular
25d
Cleared
Dec 01, 2017
Octane aspiration system
Vascular Solutions, Inc.
Cardiovascular
51d
Cleared
Jul 16, 2013
EXPORT ADVANCE ASPIRATION CATHETER
Medtronic, Inc.
Cardiovascular
137d
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 510(k) Review Time - QEZ Product Code
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 →