510(k) K001509

STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE by Cobe Cardiovascular, Inc. — Product Code DWF

K001509 is an FDA 510(k) premarket notification submitted by Cobe Cardiovascular, Inc. for the device "STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE". The FDA issued a decision of Substantially Equivalent on October 26, 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. Cobe Cardiovascular, Inc. has at least 10 other 510(k) clearances on record.