510(k) K031700

MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 by Medtronic Perfusion Systems — Product Code DTN

K031700 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711". The FDA issued a decision of Substantially Equivalent on August 29, 2003. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.