510(k) K111417

THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER by Access Scientific, Inc. — Product Code DYB

K111417 is an FDA 510(k) premarket notification submitted by Access Scientific, Inc. for the device "THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER". The FDA issued a decision of Substantially Equivalent on July 15, 2011. 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.