Cleared Special

VDRIVE WITH V-SONO

K133396 · Stereotaxis, Inc. · Cardiovascular
Feb 2014
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K133396 is an FDA 510(k) clearance for the VDRIVE WITH 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 February 6, 2014, 92 days after receiving the submission on November 6, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K133396 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2013
Decision Date February 06, 2014
Days to Decision 92 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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