510(k) K050109

TRILLIUM BIOPUMP PLUS, MODEL BPX80T by Medtronic Perfusion Systems — Product Code KFM

K050109 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "TRILLIUM BIOPUMP PLUS, MODEL BPX80T". The FDA issued a decision of Substantially Equivalent on February 11, 2005. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.