Cleared Traditional

VDRIVE W/V-SONO

K122659 · Stereotaxis, Inc. · Cardiovascular
Jul 2013
Decision
329d
Days
Class 2
Risk

About This 510(k) Submission

K122659 is an FDA 510(k) clearance for the VDRIVE W/V-SONO, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 26, 2013, 329 days after receiving the submission on August 31, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K122659 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2012
Decision Date July 26, 2013
Days to Decision 329 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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