DeviceClearance

Product code QEX— Cardiovascular

INDIGO Aspiration System

Classification name
Coronary Mechanical Thrombectomy With Aspiration
Device class
Class 2
Regulation
21 CFR 870.5150
Advisory panel
Cardiovascular
Total cleared
3
First cleared
Most recent

FDA classification definition

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

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

Market context for product code QEX

FDA has cleared 3 devices under product code QEX between 2017 and 2025, filed by 3 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

Top applicants under product code QEX

Recent clearances under product code QEX

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