510(k) K063290

GAMBRO QUICKSET BLOODLINES by Gambro Renal Products — Product Code FJK

K063290 is an FDA 510(k) premarket notification submitted by Gambro Renal Products for the device "GAMBRO QUICKSET BLOODLINES". The FDA issued a decision of Substantially Equivalent on January 30, 2007. 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. Gambro Renal Products has at least 10 other 510(k) clearances on record.