Home › FEops › FEops

FEops

FEops · Model 1.4.2 · UDI-DI 05430002070070

QQI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.