510(k) K896414

VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN by Baxter Healthcare Corp — Product Code DTN

K896414 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN". The FDA issued a decision of Substantially Equivalent on Jan 31, 1990. 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.