DeviceClearance

Product code QEY— Cardiovascular

LYSUS INFUSION SYSTEM

Classification name
Mechanical Thrombolysis Catheter
Device class
Class 2
Regulation
21 CFR 870.5150
Advisory panel
Cardiovascular
Total cleared
71
First cleared
Most recent

FDA classification definition

“To mechanically disrupt thrombus and/or debris in the peripheral vasculature.”

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

Market context for product code QEY

FDA has cleared 71 devices under product code QEY between 1995 and 2026, filed by 18 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 QEY

Recent clearances under product code QEY

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