510(k) K153158

Solution Administration Sets with 0.2 Micron Filter by Baxter Healthcare Corporation — Product Code FPA

K153158 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Solution Administration Sets with 0.2 Micron Filter". The FDA issued a decision of Substantially Equivalent on Dec 28, 2015. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.