510(k) K161313

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — Product Code PND

K161313 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) for the device "ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology". The FDA issued a decision of Substantially Equivalent on August 24, 2016. The device falls under product code PND (Midline Catheter), a Class II device regulated under 21 CFR 880.5200. Arrow International, Inc. (Subsidiary of Teleflex, Inc.) has at least 7 other 510(k) clearances on record.