← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

QEW — Peripheral Mechanical Thrombectomy With Aspiration

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

DEVICE CLASS
Class II
REGULATION
21 CFR 870.5150
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
22
510(K)/PMA CLEARANCES
510k: 22
0
RECALL ENTRIES

Recent clearances

K260599Penumbra, Inc. · 510k2026-04-24
K260028Argon Medical Devices, Inc. · 510k2026-02-05
K251949Penumbra, Inc. · 510k2026-02-05
K253730Verge Medical, Inc. · 510k2026-01-21
K251207Avantec Vascular Corporation · 510k2026-01-07
K252956Endovascular Engineering, Inc. · 510k2025-12-18
K251070Akura Medical · 510k2025-11-25
K253323Inari Medical · 510k2025-10-29

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →