Cleared Traditional

ENDOVASCULAR GUIDE WIRE

K021363 · Stereotaxis, Inc. · Cardiovascular
Nov 2002
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K021363 is an FDA 510(k) clearance for the 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 November 27, 2002, 211 days after receiving the submission on April 30, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K021363 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2002
Decision Date November 27, 2002
Days to Decision 211 days
Submission Type Traditional
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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