510(k) Report

Devices descending from DEN140009

3 later devices reach Amigo Remote Catheter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183027Steerable catheter control systemStereotaxis, Inc.20192—
+2K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc.201911
+3K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc.20200—