510(k) K092318

BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE by Baxter Healthcare Corporation — Product Code LHI

K092318 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE". The FDA issued a decision of Substantially Equivalent on Oct 30, 2009. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.