Cleared Special

STEREOTAXIS ENDOVASCULAR GUIDE WIRE

K042854 · Stereotaxis, Inc. · Cardiovascular
Feb 2005
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K042854 is an FDA 510(k) clearance for the STEREOTAXIS 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 8, 2005, 116 days after receiving the submission on October 15, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K042854 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2004
Decision Date February 08, 2005
Days to Decision 116 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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