← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

QEZ — Aspiration Thrombectomy Catheter

To remove thrombus from the peripheral and/or coronary 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
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K262030Inquis Medical · 510k2026-07-15
K253589Medtronic Interventional Vascular, Inc. · 510k2026-04-23
K254208Expanse Medical, Inc. · 510k2026-03-20
K253925Inquis Medical · 510k2026-01-15
K252509AngioDynamics, Inc. · 510k2025-11-24
K251312Vesalio, Inc. · 510k2025-10-24
K251488Expanse Medical, Inc. · 510k2025-07-14
K243549ABBOTT MEDICAL · 510k2025-04-04

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 →