510(k) K043574

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 by Renal Solutions, Inc. — Product Code FKT

K043574 is an FDA 510(k) premarket notification submitted by Renal Solutions, Inc. for the device "ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000". The FDA issued a decision of Substantially Equivalent on June 3, 2005. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Renal Solutions, Inc. has at least 8 other 510(k) clearances on record.