510(k) K242451

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) by Edwards Lifesciences — Product Code DYG

K242451 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)". The FDA issued a decision of Substantially Equivalent on December 9, 2024. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Edwards Lifesciences has at least 10 other 510(k) clearances on record.