510(k) K933713

VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT by Baxter Healthcare Corp — Product Code DTN

K933713 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT". The FDA issued a decision of Substantially Equivalent on Mar 1, 1994. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Baxter Healthcare Corp has 507 other 510(k) clearances on record.