FEops HEARTguide— 510(k) K214066

Substantially Equivalent

Feops NV

FDA 510(k) clearance K214066 for FEops HEARTguide, Substantially Equivalent on 2022-02-25. 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: 2021-12-27
Decision date: 2022-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gent-Zwijnaarde, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QQI

K250635 — FEops HEARTguide Simulation Application2025-11-25
K223809 — PrecisionTAVI (v1.1)2023-05-30
DEN200030 — FEops HEARTguide2021-09-08

More clearances from Feops NV

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

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