510(k) K941225

UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT by Baxter Healthcare Corp — Product Code DTZ

K941225 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT". The FDA issued a decision of Substantially Equivalent on Aug 16, 1994. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Baxter Healthcare Corp has 507 other 510(k) clearances on record.