# K214066: FEops HEARTguide

- Pathway: 510(k) (Traditional)
- Applicant: Feops NV
- Decided: Feb 25, 2022 after 60 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: 1 generation back to DEN200030 (2021). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200030: FEops HEARTguide, Feops NV (2021) Summary page 4.

## Most influential descendants
- K250635: FEops HEARTguide Simulation Application (2025), 0 descendants of its own
- K223809: PrecisionTAVI (v1.1) (2023), 0 descendants of its own

## Indications for use
FEops HEARTguide™ 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™ 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™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.

Source page: https://510kreport.com/device/K214066
Methodology: https://510kreport.com/methodology