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.
FDA 510(k) Cleared Peripheral Mechanical Thrombectomy With Aspiration Devices (Product Code QEW)
About Product Code QEW - Regulatory Context
510(k) Submission Activity
141 total 510(k) submissions under product code QEW since 2000, with 141 receiving FDA clearance (average review time: 104 days).
Submission volume has declined in recent years - 27 submissions in the last 24 months compared to 37 in the prior period.
FDA Review Time
Recent submissions under QEW have taken an average of 88 days to reach a decision - down from 108 days historically, suggesting improved FDA processing for this classification.
QEW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →