510(k) K022762

JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 by Jomed, Inc. — Product Code DQX

K022762 is an FDA 510(k) premarket notification submitted by Jomed, Inc. for the device "JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050". The FDA issued a decision of Substantially Equivalent on December 16, 2002. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Jomed, Inc. has at least 8 other 510(k) clearances on record.