510(k) K820859

COAXIAL DUAL FLOW CATHETER by Terumo Medical Corp. — Product Code LBW

K820859 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "COAXIAL DUAL FLOW CATHETER". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code LBW (Set, Dialysis, Single Needle (Co-Axial Flow)), a Class II device regulated under 21 CFR 876.5540. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.