510(k) K082425

TANDEMHEART TRANSSEPTAL CANNULA- EF 72 by Cardiacassist, Inc. — Product Code DWF

K082425 is an FDA 510(k) premarket notification submitted by Cardiacassist, Inc. for the device "TANDEMHEART TRANSSEPTAL CANNULA- EF 72". The FDA issued a decision of Substantially Equivalent on September 18, 2008. 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.