DeviceClearance

Product code QEZ— Cardiovascular

ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039

Classification name
Aspiration Thrombectomy Catheter
Device class
Class 2
Regulation
21 CFR 870.5150
Advisory panel
Cardiovascular
Total cleared
95
First cleared
Most recent

FDA classification definition

“To remove thrombus from the peripheral and/or coronary vasculature through aspiration.”

— U.S. Food and Drug Administration, device classification record for product code QEZ under 21 CFR 870.5150, via openFDA

Market context for product code QEZ

FDA has cleared 95 devices under product code QEZ between 1999 and 2026, filed by 34 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code QEZ

Adverse events under product code QEZ

product code QEZ
Death
24
Total
24

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QEZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.