MODIFICATION TO ENDOVASCULAR GUIDE WIRE

About This 510(k) Submission

K043457 is an FDA 510(k) clearance for the MODIFICATION TO ENDOVASCULAR GUIDE WIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on February 28, 2005, 75 days after receiving the submission on December 15, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.