DeviceClearance

Product code QEW— Cardiovascular

ClotTriever Thrombectomy System

Classification name
Peripheral Mechanical Thrombectomy With Aspiration
Device class
Class 2
Regulation
21 CFR 870.5150
Advisory panel
Cardiovascular
Total cleared
143
First cleared
Most recent

FDA classification definition

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

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

Market context for product code QEW

FDA has cleared 143 devices under product code QEW between 2000 and 2026, filed by 44 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 QEW

Adverse events under product code QEW

product code QEW
Death
126
Injury
282
Malfunction
820
Total
1,228

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 QEW

1–100 of 143

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