510(k) K121748

THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL by Access Scientific, Inc. — Product Code DYB

K121748 is an FDA 510(k) premarket notification submitted by Access Scientific, Inc. for the device "THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL". The FDA issued a decision of Substantially Equivalent on July 27, 2012. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Access Scientific, Inc. has at least 10 other 510(k) clearances on record.