Cleared Traditional

Vdrive system, Vdrive Duo, Vdrive with V-Sono

K150312 · Stereotaxis, Inc. · Cardiovascular
Jun 2015
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K150312 is an FDA 510(k) clearance for the Vdrive system, Vdrive Duo, Vdrive with V-Sono, a System, Catheter Control, Steerable (Class II — Special Controls, product code DXX), submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 17, 2015, 128 days after receiving the submission on February 9, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K150312 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2015
Decision Date June 17, 2015
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXX — System, Catheter Control, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1290