510(k) K070739

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 by Renal Solutions, Inc. — Product Code FKT

K070739 is an FDA 510(k) premarket notification submitted by Renal Solutions, Inc. for the device "ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500". The FDA issued a decision of Substantially Equivalent on May 25, 2007. 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.