510(k) K070320

EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 by Edwards Lifesciences Services GmbH — Product Code KDI

K070320 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences Services GmbH for the device "EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01". The FDA issued a decision of Substantially Equivalent on June 7, 2007. 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. Edwards Lifesciences Services GmbH has at least 2 other 510(k) clearances on record.