510(k) K161808

Solution Set with 1.2 Micron Air Eliminating Filter by Baxter Healthcare Corporation — Product Code FPA

K161808 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Solution Set with 1.2 Micron Air Eliminating Filter". The FDA issued a decision of Substantially Equivalent on Jun 21, 2017. 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.