510(k) K032962

AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE by Arrow Intl., Inc. — Product Code FOZ

K032962 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE". The FDA issued a decision of Substantially Equivalent on October 29, 2003. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Arrow Intl., Inc. has at least 10 other 510(k) clearances on record.