FDA Product Code QQI: Interventional Cardiovascular Implant Simulation Software Device
An Interventional Cardiovascular Implant Simulation Software Device Is A Prescription Device That Provides A Computer Simulation Of An Interventional Cardiovascular Implant Device Inside A Patients Cardiovascular Anatomy. It Performs Computational Modeling To Predict The Interaction Of The Interventional Cardiovascular Implant Device With The Patient-specific Anatomical Environment.
Leading manufacturers include Feops NV and Dasi Simulations.
FDA 510(k) Cleared Interventional Cardiovascular Implant Simulation Software Device Devices (Product Code QQI)
About Product Code QQI - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QQI since 2021, with 3 receiving FDA clearance (average review time: 244 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for QQI submissions have been consistent, averaging 267 days recently vs 237 days historically.
QQI devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →