510(k) K100635

ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 by Arrow Intl., Inc. — Product Code LJS

K100635 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504". The FDA issued a decision of Substantially Equivalent on August 27, 2010. 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 Intl., Inc. has at least 10 other 510(k) clearances on record.