510(k) K974736

HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER by Heartport, Inc. — Product Code DWF

K974736 is an FDA 510(k) premarket notification submitted by Heartport, Inc. for the device "HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER". The FDA issued a decision of Substantially Equivalent on July 15, 1998. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Heartport, Inc. has at least 10 other 510(k) clearances on record.