Product code PJB

Device name: Catheter Remote Control System
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.5700
Review panel: CV
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K193147	Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System	Stereotaxis, Inc.	2020-03-05
K192775	Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri	Stereotaxis, Inc.	2019-10-30
K183027	Steerable catheter control system	Stereotaxis, Inc.	2019-09-06
DEN140009	AMIGO REMOTE CATHETER SYSTEM	Catheter Robotics, Inc.	2014-12-18

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
M588020004500370	Navigant	Stereotaxis, Inc.	2023-04-25
M58800101100010	Genesis (RMNS)	Stereotaxis, Inc.	2020-08-20
M58800101100030	Genesis MNS with Model-S	Stereotaxis, Inc.	2020-08-20

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