Cleared Special

CARDIODRIVE CATHETER ADVANCEMENT SYSTEM

K051374 · Stereotaxis, Inc. · Cardiovascular
Jun 2005
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K051374 is an FDA 510(k) clearance for the CARDIODRIVE CATHETER ADVANCEMENT SYSTEM, 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 June 23, 2005, 28 days after receiving the submission on May 26, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K051374 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2005
Decision Date June 23, 2005
Days to Decision 28 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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