Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri

FDA 510(k) K192775 · Stereotaxis, Inc.

Substantially Equivalent

510(k) numberK192775

Submission

Device name
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
Applicant
Stereotaxis, Inc.
St. Louis, MO, US
Received
September 30, 2019
Decision date
October 30, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PJB – Catheter Remote Control System
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5700
Specialty
Cardiovascular

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…

Other 510(k)s with product code PJB

510(k)DeviceApplicantDecision
K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemPJB · Traditional Stereotaxis, Inc.03/05/2020SE
K183027Steerable catheter control systemPJB · Traditional Stereotaxis, Inc.09/06/2019SE

More from Stereotaxis, Inc.

510(k)DeviceDecision
K262744GenesisX RMNDXX · Special 08/27/2026SE
K253473SynchronyDQK · Traditional 04/01/2026SE
K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)DXX · Traditional 11/06/2025SE
K250590MAGiC Sweep™ EP Mapping CatheterDRF · Traditional 07/23/2025SE
K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemPJB · Traditional 03/05/2020SE
K183027Steerable catheter control systemPJB · Traditional 09/06/2019SE
K150312Vdrive system, Vdrive Duo, Vdrive with V-SonoDXX · Traditional 06/17/2015SE
K141530Vdrive System/ Vdrive Duo/ Vdrive with V-CasDXX · Traditional 12/18/2014SE
K140804Vdrive with V-Loop/ Vdrive DuoDXX · Traditional 09/03/2014SE
K133396Vdrive with V-SonoDQX · Special 02/06/2014SE

Questions and answers

When was Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri cleared by the FDA?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (K192775) received a 510(k) decision of Substantially Equivalent on October 30, 2019, 30 days after the submission was received.

What is the product code of K192775?

The FDA product code is PJB – Catheter Remote Control System, a Class II (moderate risk) device regulated under 21 CFR 870.5700.