510(k) K011761

MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT by Arrow Intl., Inc. — Product Code DYB

K011761 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT". The FDA issued a decision of Substantially Equivalent on October 31, 2001. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Arrow Intl., Inc. has at least 10 other 510(k) clearances on record.