510(k) K991170

RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 by Edwards Lifesciences Research Medical — Product Code DWF

K991170 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences Research Medical for the device "RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014". The FDA issued a decision of Substantially Equivalent on July 2, 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.