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FEops 3.0.1 FEops

Company Name

FEops

Catalog Number

3.0.1

Description

FEops HEARTguide ALPACA 3.0.1 / 3.0.2

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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 1.4.2 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

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FEops 1.4.1 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 1.4.2 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 1.4.1 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 1.4.2 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

Additional Details

Device Identifier

05430002070063

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

No

Is Single Use

No

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	05430002070063