QQI

Interventional Cardiovascular Implant Simulation Software Device

Product code

QQI

Device name

Interventional Cardiovascular Implant Simulation Software Device

Device class

Class 2

21 CFR

21 CFR 870.1405

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-11-25.

1 summaries are archived here for direct download.