Cleared Traditional

K250635 - FEops HEARTguide Simulation Application (FDA 510(k) Clearance)

K250635 · Feops NV · Cardiovascular device
Nov 2025
Decision
267d
Days
Class 2
Risk

K250635 is an FDA 510(k) clearance for the FEops HEARTguide Simulation Application. This device is classified as a Interventional Cardiovascular Implant Simulation Software Device (Class II - Special Controls, product code QQI).

Submitted by Feops NV (Gent, BE). The FDA issued a Cleared decision on November 25, 2025, 267 days after receiving the submission on March 3, 2025.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1405. 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..

Submission Details

510(k) Number K250635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2025
Decision Date November 25, 2025
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QQI - Interventional Cardiovascular Implant Simulation Software Device
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1405
Definition 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.