FEops HEARTguide Simulation Application— 510(k) K250635

Name: FDA 510(k) clearance K250635
Creator: U.S. Food and Drug Administration
Published: 2025-11-25

Substantially Equivalent

Feops NV

FDA 510(k) clearance K250635 for FEops HEARTguide Simulation Application, Substantially Equivalent on 2025-11-25. Applicant: Feops NV. Device class: 2.

Clearance details

Applicant: Feops NV
Product code: Code QQI
Device class: Class 2
Regulation: 21 CFR 870.1405
Advisory panel: Cardiovascular
Date received: 2025-03-03
Decision date: 2025-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gent, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QQI

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K223809 — PrecisionTAVI (v1.1)2023-05-30
K214066 — FEops HEARTguide2022-02-25
DEN200030 — FEops HEARTguide2021-09-08

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K223855 — FEops HEARTguideTM, FEops HEARTguideTM ALPACA2023-06-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.