510(k) K081697

THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 by Access Scientific, Inc. — Product Code DYB

K081697 is an FDA 510(k) premarket notification submitted by Access Scientific, Inc. for the device "THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006". The FDA issued a decision of Substantially Equivalent on December 4, 2008. 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.