510(k) K053609

PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR by Edwards Lifesciences, LLC — Product Code DQE

K053609 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR". The FDA issued a decision of Substantially Equivalent on February 28, 2006. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.