510(k) K932208

EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM by Baxter Healthcare Corp — Product Code DWF

K932208 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM". The FDA issued a decision of Substantially Equivalent on Aug 9, 1994. 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 Healthcare Corp has 507 other 510(k) clearances on record.