510(k) K000028

RENAFLO II HF 2000 HEMOFILTER by Minntech Corp. — Product Code KDI

K000028 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "RENAFLO II HF 2000 HEMOFILTER". The FDA issued a decision of Substantially Equivalent on April 4, 2000. 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. Minntech Corp. has at least 10 other 510(k) clearances on record.