DeviceClearance

Product code QQI— Cardiovascular

FEops HEARTguide

Classification name
Interventional Cardiovascular Implant Simulation Software Device
Device class
Class 2
Regulation
21 CFR 870.1405
Advisory panel
Cardiovascular
Total cleared
4
First cleared
Most recent

FDA classification definition

“An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.”

— U.S. Food and Drug Administration, device classification record for product code QQI under 21 CFR 870.1405, via openFDA

Market context for product code QQI

FDA has cleared 4 devices under product code QQI between 2021 and 2025, filed by 2 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 QQI

Recent clearances under product code QQI

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