510(k) K990643

PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 by Althin Medical AB an Affiliate of Baxter Intl — Product Code KDI

K990643 is an FDA 510(k) premarket notification submitted by Althin Medical AB an Affiliate of Baxter Intl for the device "PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015". The FDA issued a decision of Substantially Equivalent on December 7, 1999. 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. Althin Medical AB an Affiliate of Baxter Intl has at least 10 other 510(k) clearances on record.