510(k) K905312

DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS by Baxter Bentley Laboratories, Inc. — Product Code DWF

K905312 is an FDA 510(k) premarket notification submitted by Baxter Bentley Laboratories, Inc. for the device "DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS". The FDA issued a decision of Substantially Equivalent on January 15, 1991. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Baxter Bentley Laboratories, Inc. has at least 2 other 510(k) clearances on record.