510(k) K993245

CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM by Alba Critical Care, Ltd. — Product Code DYG

K993245 is an FDA 510(k) premarket notification submitted by Alba Critical Care, Ltd. for the device "CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM". The FDA issued a decision of Substantially Equivalent on October 28, 1999. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240.