510(k) K253034

HemoSphere Stream Module by Edwards Lifesciences — Product Code DQK

K253034 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "HemoSphere Stream Module". The FDA issued a decision of Substantially Equivalent on October 21, 2025. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Edwards Lifesciences has at least 10 other 510(k) clearances on record.