510(k) K181563

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology by Access Scientific, LLC — Product Code DQY

K181563 is an FDA 510(k) premarket notification submitted by Access Scientific, LLC for the device "The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology". The FDA issued a decision of Substantially Equivalent on September 26, 2018. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Access Scientific, LLC has at least 10 other 510(k) clearances on record.