FDA Product Code QEW: Peripheral Mechanical Thrombectomy With Aspiration
FDA product code QEW covers peripheral mechanical thrombectomy systems with aspiration.
These devices are designed to mechanically disrupt and remove thrombus from peripheral arteries and veins. They combine mechanical fragmentation with aspiration to restore blood flow in patients with acute limb ischemia or deep vein thrombosis.
QEW devices are Class II medical devices, regulated under 21 CFR 870.5150 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Inari Medical, Inc., Penumbra, Inc. and Inari Medical.
List of Peripheral Mechanical Thrombectomy With Aspiration devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Peripheral Mechanical Thrombectomy With Aspiration devices (product code QEW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →