510(k) K921550

LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP by St. Jude Medical, Inc. — Product Code KFM

K921550 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP". The FDA issued a decision of Substantially Equivalent on May 21, 1992. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. St. Jude Medical, Inc. has at least 10 other 510(k) clearances on record.