510(k) K071538

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER by Arrow International, Inc. — Product Code FOZ

K071538 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. for the device "ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER". The FDA issued a decision of Substantially Equivalent on August 30, 2007. 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 International, Inc. has at least 10 other 510(k) clearances on record.