510(k) K162322

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model by Access Scientific, LLC — Product Code DYB

K162322 is an FDA 510(k) premarket notification submitted by Access Scientific, LLC for the device "the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model". The FDA issued a decision of Substantially Equivalent on November 17, 2016. 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.