510(k) K131666

ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING by Maquet Cardiopulmonary, AG — Product Code DWF

K131666 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING". The FDA issued a decision of Substantially Equivalent on July 5, 2013. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Maquet Cardiopulmonary, AG has at least 10 other 510(k) clearances on record.