FDA Product Code PJB: Catheter Remote Control System
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.
Leading manufacturers include Stereotaxis, Inc..
4
Total
3
Cleared
189d
Avg days
2014
Since
FDA 510(k) Cleared Catheter Remote Control System Devices (Product Code PJB)
4 devices
Cleared
Mar 05, 2020
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
Stereotaxis, Inc.
Cardiovascular
113d
Cleared
Oct 30, 2019
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
Stereotaxis, Inc.
Cardiovascular
30d
Cleared
Sep 06, 2019
Steerable catheter control system
Stereotaxis, Inc.
Cardiovascular
309d