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510(k) K214066

Device
FEops HEARTguide
Applicant
FEops Nv
510(k) number
K214066
Product code
QQI  
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-25
Date received
2021-12-27
Regulation
870.1405
Classification name
Interventional Cardiovascular Implant Simulation Software Device
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Peter Mortier
Address
Technologiepark 122 Gent-Zwijnaarde BE 9052 9052

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QQI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250635FEops HEARTguide Simulation ApplicationFeops NV2025-11-25
K223809PrecisionTAVI (v1.1)Dasi Simulations2023-05-30
DEN200030FEops HEARTguideFeops NV2021-09-08

Legacy Summary#

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FDA Review#

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