510(k) K002857

ELS CANNULA (KIT), MODEL M1210-88,M1510-88 by Jostra AG — Product Code DWF

K002857 is an FDA 510(k) premarket notification submitted by Jostra AG for the device "ELS CANNULA (KIT), MODEL M1210-88,M1510-88". The FDA issued a decision of Substantially Equivalent on October 5, 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. Jostra AG has at least 10 other 510(k) clearances on record.