# DEN200030: FEops HEARTguide

- Pathway: De Novo (Direct)
- Applicant: Feops NV
- Decided: Sep 8, 2021 after 489 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
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K214066: FEops HEARTguide (2022), 2 descendants of its own
- 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’s instructions for use for final LAAO device selection and placement. FEops HEARTguide is prescription use only.

Source page: https://510kreport.com/device/DEN200030
Methodology: https://510kreport.com/methodology