510(k) K983791

PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA by Edwards Lifesciences Research Medical — Product Code DWF

K983791 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences Research Medical for the device "PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA". The FDA issued a decision of Substantially Equivalent on June 11, 1999. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Edwards Lifesciences Research Medical has at least 5 other 510(k) clearances on record.