510(k) K113277

ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS by Arrow International, Inc. — Product Code LJS

K113277 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. for the device "ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS". The FDA issued a decision of Substantially Equivalent on June 21, 2012. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Arrow International, Inc. has at least 10 other 510(k) clearances on record.