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QEX — Coronary Mechanical Thrombectomy With Aspiration Class II

FDA Device Classification

Classification Details

Product Code
QEX
Device Class
Class II
Regulation Number
870.5150
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253407vesalioNeVa PV Thrombectomy DeviceNovember 24, 2025
K171493capture vascularMegaVac Mechanical Thrombectomy SystemAugust 10, 2017
K163618penumbraINDIGO Aspiration SystemMay 24, 2017