Cardiovascular · 510(k) · 2025
FEops HEARTguide Simulation Application
Feops NV. Cleared by FDA on 25 November 2025 under submission K250635, product code QQI (interventional cardiovascular implant simulation software device). What FDA's record says, in FDA's words.
Device record · K250635
- Device. FEops HEARTguide Simulation ApplicationDEVICE
- Company. Feops NV (BE)COMPANY
- Decision. 25 November 2025, 510(k), substantially equivalent (traditional review); received 3 March 2025DECISION
- Panel. CardiovascularPANEL
- Product code. QQI, Interventional Cardiovascular Implant Simulation Software DeviceCODE
- Regulation. 21 CFR 870.1405, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patients cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QQI. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QQI, in Cardiovascular, from Feops NV, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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