510(k) K231248

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform by Edwards Lifesciencess, LLC — Product Code DYG

K231248 is an FDA 510(k) premarket notification submitted by Edwards Lifesciencess, LLC for the device "Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform". The FDA issued a decision of Substantially Equivalent on September 21, 2023. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240.