510(k) K993818

ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE by California Medical Laboratories, Inc. — Product Code DWF

K993818 is an FDA 510(k) premarket notification submitted by California Medical Laboratories, Inc. for the device "ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE". The FDA issued a decision of Substantially Equivalent on February 8, 2000. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. California Medical Laboratories, Inc. has at least 2 other 510(k) clearances on record.