Coronary Mechanical Thrombectomy With Aspiration

FDA product code QEX · Class II (moderate risk) · 21 CFR 870.5150 · Cardiovascular

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

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K253407NeVa PV Thrombectomy DeviceQEX · Traditional Vesalio, Inc.11/24/2025SESU
K171493MegaVac Mechanical Thrombectomy SystemQEX · Special Capture Vascular, Inc.08/10/2017SE
K163618INDIGO Aspiration SystemQEX · Traditional Penumbra, Inc.05/24/2017SESU