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FEops

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30207036623020703662FEOPS NV1N2026-01-01Technologiepark-Zwijnaarde 122 Gent Oost-Vlaanderen BE 9052

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2968211566093148K250635FEops HEARTguide Simulation ApplicationQQI2025-11-25
2968211631345033K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAQIH2023-06-06
2968212025752710K214066FEops HEARTguideQQI2022-02-25
2968211783826091DEN200030FEops HEARTguideQQI2021-09-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QQI32025-11-25
QIH12023-06-06

PMN#

GUDID#

FEops - FEops HEARTguide™ 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™ 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™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.FEops HEARTguide™ is prescription use only.

FEops

2021-11-30

FEops - FEops HEARTguide™ 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™ 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™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.The version v1.4.2 supports next to the WATCHMAN device also the WATCHMAN FLX and the AMULET devices

FEops

2022-03-29