510(k) K183066

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model by Access Scientific, LLC — Product Code DYB

K183066 is an FDA 510(k) premarket notification submitted by Access Scientific, LLC for the device "The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model". The FDA issued a decision of Substantially Equivalent on July 25, 2019. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Access Scientific, LLC has at least 10 other 510(k) clearances on record.