FDA 510(k) Applications Submitted by Varad Raghuwanshi

FDA 510(k) Number	Submission Date	Device Name	Applicant
K230057	01/09/2023	Acumen Hypotension Prediction Index (HPI) Algorithm	Edwards Lifesciences LLC
K201446	06/01/2020	HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module	Edwards Lifesiences, LLC
K221833	06/23/2022	HemoSphere Advanced Monitor, HemoSphere ClearSight Module	Edwards Life Sciences LLC
K232294	08/01/2023	HemoSphere Alta Advanced Monitoring Platform; HemoSphere AltaÖ Advanced Monitor (Smart Recovery); HemoSphere AltaÖ Advanced Monitor (Cardiac); HemoSphere AltaÖ Advanced Monitor (All-on-One)	Edwards Lifesciences, LLC
K242451	08/16/2024	HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)	Edwards LifeSciences
K243781	12/09/2024	HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HE	Edwards Lifesciences
K203687	12/17/2020	HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index	Edwards lifesciences, LLC