510(k) K022634

CO-AXIAL INTRODUCER NEEDLE by Promex, Inc. — Product Code DYB

K022634 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "CO-AXIAL INTRODUCER NEEDLE". The FDA issued a decision of Substantially Equivalent on November 6, 2002. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Promex, Inc. has at least 10 other 510(k) clearances on record.