510(k) Report

Devices descending from K071029

8 later devices reach Cardiodrive Catheter Advancement System (Cas) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183027Steerable catheter control systemStereotaxis, Inc.20192—
+1K141530Vdrive System/ Vdrive Duo/ Vdrive with V-CasStereotaxis, Inc.20141—
+1K122659Vdrive W/V-SonoStereotaxis, Inc.20134—
+2K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc.201911
+2K150312Vdrive system, Vdrive Duo, Vdrive with V-SonoStereotaxis, Inc.20150—
+2K140804Vdrive with V-Loop/ Vdrive DuoStereotaxis, Inc.20142—
+2K133396Vdrive with V-SonoStereotaxis, Inc.20142—
+3K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc.20200—