510(k) K012743

TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T by Medtronic Perfusion Systems — Product Code DRY

K012743 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T". The FDA issued a decision of Substantially Equivalent on September 14, 2001. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.