510(k) K903925

ARIES MELDICAL MODEL 2100HC HANK CRANK by Aries Medical, Inc. — Product Code KFM

K903925 is an FDA 510(k) premarket notification submitted by Aries Medical, Inc. for the device "ARIES MELDICAL MODEL 2100HC HANK CRANK". The FDA issued a decision of Substantially Equivalent on December 21, 1990. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Aries Medical, Inc. has at least 10 other 510(k) clearances on record.