510(k) K974155

BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT by Baxter Healthcare Corp — Product Code DTN

K974155 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT". The FDA issued a decision of Substantially Equivalent on Jan 22, 1998. 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.