Device type
Peripheral Mechanical Thrombectomy With Aspiration
Product code QEW · Class II · 21 CFR 870.5150 · Cardiovascular
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Recent 510(k)s
Oct 15, 2026
K262904
INDIGO® Aspiration System
Penumbra, Inc.
- QEW
- Class II
Sep 18, 2026
K253419
Triever Duo Catheter
Inari Medical, Inc.
- QEW
- Class II
Sep 3, 2026
K261800
Helo Max Thrombectomy System (HEL2090)
Endovascular Engineering
- QEW
- Class II
Aug 21, 2026
K262538
Artix™ MT;Artix™ Thin-Walled Sheath
Inari Medical, Inc.
- QEW
- Class II
Recent recalls
No recalls in the archive for QEW.