QEX

Coronary Mechanical Thrombectomy With Aspiration

Product code
QEX
Device name
Coronary Mechanical Thrombectomy With Aspiration
Device class
Class 2
21 CFR
21 CFR 870.5150
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

FDA classification definition

To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-11-24.

NumberDecision dateApplicantDevice nameSummary
K2534072025-11-24Vesalio, Inc.NeVa PV Thrombectomy DevicePDF

1 summaries are archived here for direct download.

Official FDA classification page: QEX
Classification and pathway per current FDA publications. Data from openFDA (CC0).