510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K214066Substantially Equivalent

FEops HEARTguide

Feops NV, Gent-Zwijnaarde, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K214066 is the FDA 510(k) clearance record for FEops HEARTguide, a class II device, cleared for Feops NV on under FDA product code QQI (Interventional Cardiovascular Implant Simulation Software Device). FDA's definition for product code QQI reads: "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...". FDA records list 3 510(k) clearances for Feops NV, from to . As of , FDA records show no recalls naming K214066.

Clearance record

Decision date
Received
(60 days to decision)
Product code
QQI Interventional Cardiovascular Implant Simulation Software Device
Regulation
21 CFR 870.1405
Device class
Class II
Review panel
Cardiovascular
Applicant
Feops NV Technologiepark 122, Gent-Zwijnaarde, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QQI

Trailing 12 months
1 clearance under product code QQI in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QQI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260