Cleared Traditional

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

K193147 · Stereotaxis, Inc. · Cardiovascular
Mar 2020
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K193147 is an FDA 510(k) clearance for the Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System, a Catheter Remote Control System (Class II — Special Controls, product code PJB), submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 5, 2020, 113 days after receiving the submission on November 13, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5700.

Submission Details

510(k) Number K193147 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2019
Decision Date March 05, 2020
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code PJB — Catheter Remote Control System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5700
Definition A Steerable Cardiac Ablation Catheter Remote Control System Is A Device That Is External To The Body And Interacts With The Manual Handle Of A Steerable Cardiac Ablation Catheter To Remotely Control The Advancement, Retraction, Rotation, And Deflection Of A Steerable Ablation Catheter Used For The Treatment Of Cardiac Arrhythmias In The Right Side Of The Heart. The Device Allows Reversion To Manual Control Of The Steerable Cardiac Ablation Catheter Without Withdrawal Of The Catheter And Interruption Of The Procedure.