HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE

About This 510(k) Submission

K060449 is an FDA 510(k) clearance for the HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Guidant Corporation (Temecula, US). The FDA issued a Cleared decision on May 30, 2006, 98 days after receiving the submission on February 21, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.