510(k) K102532

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

K102532 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING". The FDA issued a decision of Substantially Equivalent on February 25, 2011. 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.