510(k) K001685

PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 by Baxter Healthcare Corp — Product Code MSE

K001685 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210". The FDA issued a decision of Substantially Equivalent on November 15, 2000. The device falls under product code MSE (Hemodialyzer, Re-Use, Low Flux), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.