Cleared Traditional

VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS

K141530 · Stereotaxis, Inc. · Cardiovascular
Dec 2014
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K141530 is an FDA 510(k) clearance for the VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS, a System, Catheter Control, Steerable (Class II — Special Controls, product code DXX), submitted by Stereotaxis, Inc. (Fairfax, US). The FDA issued a Cleared decision on December 18, 2014, 192 days after receiving the submission on June 9, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K141530 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2014
Decision Date December 18, 2014
Days to Decision 192 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