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FDA 510(k) Applications for Medical Device Product Code "PJB"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN140009
CATHETER ROBOTICS INC
AMIGO REMOTE CATHETER SYSTEM
12/18/2014
K192775
Stereotaxis, Inc.
Niobe« Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
10/30/2019
K183027
Stereotaxis, Inc.
Steerable catheter control system
09/06/2019
K193147
Stereotaxis, Inc.
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
03/05/2020
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