510(k) K964571

VISION CARDIOPLEGIA DELIVERY SYSTEM by Lifestream Int'L, Inc. — Product Code DTR

K964571 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "VISION CARDIOPLEGIA DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 8, 1997. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.