# K250635: FEops HEARTguide Simulation Application

- Pathway: 510(k) (Traditional)
- Applicant: Feops NV
- Decided: Nov 25, 2025 after 267 days
- Product code: QQI (Interventional Cardiovascular Implant Simulation Software Device)
- Device class: 2
- Regulation: 21 CFR 870.1405
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN200030 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214066: FEops HEARTguide, Feops NV (2022) Summary page 5.

## Indications for use
FEops HEARTguide™ Simulation Application is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning. The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement. FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment. FEops HEARTguide™ Simulation Application is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.

Source page: https://510kreport.com/device/K250635
Methodology: https://510kreport.com/methodology