510(k) K832124

CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI by Med-West, Inc. — Product Code DWF

K832124 is an FDA 510(k) premarket notification submitted by Med-West, Inc. for the device "CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Med-West, Inc. has at least 10 other 510(k) clearances on record.