510(k) K112893

CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS by Baxter Healthcare Corporation — Product Code FPA

K112893 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS". The FDA issued a decision of Substantially Equivalent on Oct 18, 2011. 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.