510(k) K131300

THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER by Access Scientific, LLC — Product Code DYB

K131300 is an FDA 510(k) premarket notification submitted by Access Scientific, LLC for the device "THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER". The FDA issued a decision of Substantially Equivalent on June 7, 2013. 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.