HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor

About This 510(k) Submission

K223865 is an FDA 510(k) clearance for the HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 9, 2023, 168 days after receiving the submission on December 23, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.