510(k) K791411

COAXIAL DUAL FLOW CATHETER by Terumo America, Inc. — Product Code KOC

K791411 is an FDA 510(k) premarket notification submitted by Terumo America, Inc. for the device "COAXIAL DUAL FLOW CATHETER". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Terumo America, Inc. has at least 10 other 510(k) clearances on record.