510(k) K090255

BLOOD TUBING SETS (STERILE FLUID PATH) by Nxstage Medical, Inc. — Product Code FJK

K090255 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "BLOOD TUBING SETS (STERILE FLUID PATH)". The FDA issued a decision of Substantially Equivalent on February 10, 2009. 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. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.