510(k) K133157

TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 by Medtronic, Inc. — Product Code DRY

K133157 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6". The FDA issued a decision of Substantially Equivalent on October 23, 2014. 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, Inc. has at least 10 other 510(k) clearances on record.