510(k) K100364

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 by Gambro Renal Products, Inc. — Product Code FJK

K100364 is an FDA 510(k) premarket notification submitted by Gambro Renal Products, Inc. for the device "GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520". The FDA issued a decision of Substantially Equivalent on November 3, 2010. 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, Inc. has at least 10 other 510(k) clearances on record.