510(k) K955818

FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER by Quest Medical, Inc. — Product Code DWF

K955818 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER". The FDA issued a decision of Substantially Equivalent on March 26, 1996. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Quest Medical, Inc. has at least 10 other 510(k) clearances on record.