1 device · 1 company · 2025
Product code QQI: Interventional Cardiovascular Implant Simulation Software Device
1 device under product code QQI, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Interventional Cardiovascular Implant Simulation Software Device. 21 CFR 870.1405, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| FEops HEARTguide Simulation ApplicationK250635 · 510(k) | Feops NV | Cardiovascular | database entry |
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