QEX · Class II · 21 CFR 870.5150

FDA Product Code QEX: Coronary Mechanical Thrombectomy With Aspiration

To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Coronary Vasculature Through Aspiration.

Leading manufacturers include Vesalio, Inc..

3
Total
3
Cleared
96d
Avg days
2017
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 55d recently vs 117d historically

FDA 510(k) Cleared Coronary Mechanical Thrombectomy With Aspiration Devices (Product Code QEX)

3 devices
1–3 of 3
Cleared Nov 24, 2025
NeVa PV Thrombectomy Device
K253407
Vesalio, Inc.
Cardiovascular · 55d

About Product Code QEX - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code QEX since 2017, with 3 receiving FDA clearance (average review time: 96 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under QEX have taken an average of 55 days to reach a decision - down from 117 days historically, suggesting improved FDA processing for this classification.

QEX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →