510(k) K771693

CLIRANS BLOOD LINES SET by Terumo America, Inc. — Product Code FJK

K771693 is an FDA 510(k) premarket notification submitted by Terumo America, Inc. for the device "CLIRANS BLOOD LINES SET". The FDA issued a decision of Substantially Equivalent on September 20, 1977. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Terumo America, Inc. has at least 10 other 510(k) clearances on record.