510(k) K130639

ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER by Maquet Cardiopulmonary, AG — Product Code DWF

K130639 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent on May 16, 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.