510(k) K024124

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT by Chf Solutions, Inc. — Product Code KDI

K024124 is an FDA 510(k) premarket notification submitted by Chf Solutions, Inc. for the device "SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT". The FDA issued a decision of Substantially Equivalent on March 14, 2003. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Chf Solutions, Inc. has at least 10 other 510(k) clearances on record.