Interventional Cardiovascular Implant Simulation Software Device

FDA product code QQI · Class II (moderate risk) · 21 CFR 870.1405 · Cardiovascular

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.

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K250635FEops HEARTguide Simulation ApplicationQQI · Traditional Feops NV11/25/2025SE
K223809PrecisionTAVI (v1.1)QQI · Traditional Dasi Simulations05/30/2023SE
K214066FEops HEARTguideQQI · Traditional Feops NV02/25/2022SE