510(k) K972159

FENWAL 40 MICRON TRANSFUSION FILTER by Baxter Healthcare Corp — Product Code CAK

K972159 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FENWAL 40 MICRON TRANSFUSION FILTER". The FDA issued a decision of Substantially Equivalent on July 23, 1997. The device falls under product code CAK (Microfilter, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.