510(k) K052570

TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 by Cardiacassist, Inc. — Product Code DWF

K052570 is an FDA 510(k) premarket notification submitted by Cardiacassist, Inc. for the device "TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221". The FDA issued a decision of Substantially Equivalent on January 17, 2006. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Cardiacassist, Inc. has at least 10 other 510(k) clearances on record.