510(k) K891583

IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES by Y — Product Code FRN

K891583 is an FDA 510(k) premarket notification submitted by Y for the device "IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES". The FDA issued a decision of Substantially Equivalent on June 9, 1989. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Y has at least 10 other 510(k) clearances on record.