FEops HEARTguide Simulation Application

FDA 510(k) K250635 · Feops NV

Substantially Equivalent

510(k) numberK250635

Submission

Device name
FEops HEARTguide Simulation Application
Applicant
Feops NV
Gent, BE
Received
March 3, 2025
Decision date
November 25, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QQI – Interventional Cardiovascular Implant Simulation Software Device
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1405
Specialty
Cardiovascular

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.

Other 510(k)s with product code QQI

510(k)DeviceApplicantDecision
K223809PrecisionTAVI (v1.1)QQI · Traditional Dasi Simulations05/30/2023SE
K214066FEops HEARTguideQQI · Traditional Feops NV02/25/2022SE

More from Feops NV

510(k)DeviceDecision
K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAQIH · Traditional 06/06/2023SE
K214066FEops HEARTguideQQI · Traditional 02/25/2022SE

Questions and answers

When was FEops HEARTguide Simulation Application cleared by the FDA?

FEops HEARTguide Simulation Application (K250635) received a 510(k) decision of Substantially Equivalent on November 25, 2025, 267 days after the submission was received.

What is the product code of K250635?

The FDA product code is QQI – Interventional Cardiovascular Implant Simulation Software Device, a Class II (moderate risk) device regulated under 21 CFR 870.1405.