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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact