510(k) K130039

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER by Gambro Renal Products, Inc. — Product Code KDI

K130039 is an FDA 510(k) premarket notification submitted by Gambro Renal Products, Inc. for the device "REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER". The FDA issued a decision of Substantially Equivalent on May 2, 2013. 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. Gambro Renal Products, Inc. has at least 10 other 510(k) clearances on record.