510(k) K053049

ALARIS SAFETY MALE LUER by Cardinal Health, Alaris Products — Product Code FPA

K053049 is an FDA 510(k) premarket notification submitted by Cardinal Health, Alaris Products for the device "ALARIS SAFETY MALE LUER". The FDA issued a decision of Substantially Equivalent on January 12, 2006. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Cardinal Health, Alaris Products has at least 8 other 510(k) clearances on record.