510(k) K052555

MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB by Rand S.R.L. — Product Code DTQ

K052555 is an FDA 510(k) premarket notification submitted by Rand S.R.L. for the device "MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB". The FDA issued a decision of Substantially Equivalent on March 15, 2006. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Rand S.R.L. has at least 3 other 510(k) clearances on record.