510(k) K160018

Arrow Quickflash Arterial Catheterization Device by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — Product Code DQX

K160018 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) for the device "Arrow Quickflash Arterial Catheterization Device". The FDA issued a decision of Substantially Equivalent on June 13, 2016. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Arrow International, Inc. (Subsidiary of Teleflex, Inc.) has at least 7 other 510(k) clearances on record.