510(k) K001961

STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE by Stoeckert Instrumente — Product Code DWF

K001961 is an FDA 510(k) premarket notification submitted by Stoeckert Instrumente for the device "STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE". The FDA issued a decision of Substantially Equivalent on January 25, 2001. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Stoeckert Instrumente has at least 10 other 510(k) clearances on record.