510(k) K915547

SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT by 3M Health Care, Sarns — Product Code KFM

K915547 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT". The FDA issued a decision of Substantially Equivalent on September 9, 1993. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. 3M Health Care, Sarns has at least 10 other 510(k) clearances on record.