510(k) K003225

SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE by Baxter Healthcare Corp — Product Code FPA

K003225 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE". The FDA issued a decision of Substantially Equivalent on Oct 19, 2000. 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.