Devices · Feops NV

FEops HEARTguide Simulation Application

Feops NV is listed for FEops HEARTguide Simulation Application (K250635). The FDA list gives November 25, 2025 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QQI as “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 patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250635

Official FDA database record

Date of final decision

November 25, 2025

Company on the FDA list

Feops NV

Lead panel

Cardiovascular

Primary product code

QQI

openFDA device name for the code

Interventional Cardiovascular Implant Simulation Software Device

Device class

2

Regulation number

870.1405

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary