510(k) K090682

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 by Edwards Lifesciences Services GmbH — Product Code KDI

K090682 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences Services GmbH for the device "EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00". The FDA issued a decision of Substantially Equivalent on November 19, 2009. 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.