510(k) K000977

COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS by Olson Medical Sales, Inc. — Product Code DTR

K000977 is an FDA 510(k) premarket notification submitted by Olson Medical Sales, Inc. for the device "COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS". The FDA issued a decision of Substantially Equivalent on March 23, 2001. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Olson Medical Sales, Inc. has at least 3 other 510(k) clearances on record.