510(k) K081289

V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE by Baxter Healthcare Corp — Product Code FPA

K081289 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE". The FDA issued a decision of Substantially Equivalent on Aug 4, 2008. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has 507 other 510(k) clearances on record.