510(k) K864784

SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS by Cd Medical, Inc. — Product Code FJK

K864784 is an FDA 510(k) premarket notification submitted by Cd Medical, Inc. for the device "SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS". The FDA issued a decision of Substantially Equivalent on January 20, 1987. 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. Cd Medical, Inc. has at least 10 other 510(k) clearances on record.