510(k) K980658

PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 by Baxter Healthcare Corp — Product Code FJI

K980658 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234". The FDA issued a decision of Substantially Equivalent on May 19, 1998. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.