510(k) Report

Devices descending from K900765

42 later devices reach Steerocath (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013484Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System…Stereotaxis, Inc.200239—
+1K955847Gyro Tip EP CatheterCardiac Assist Devices, Inc.19971—
+2K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.20250—
+2K051373Cronus Guidewire, Model 001-001470-1Stereotaxis, Inc.20050—
+2K032937Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500Stereotaxis, Inc.20044—
+2K021555Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc.200335—
+2K022565Telstar Biplane Digital Imaging System [Tis] Model 030-000915Stereotaxis, Inc.20020—
+2K012520Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model GTL-20ECardiac Assist Devices, Inc.20020—
+3K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc.20251—
+3K113628Amigo Remote Catheter System (RCS) & AccessoriesCatheter Robotics, Inc.20121—
+3K052480Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable…Hansen Medical, Inc.2007272
+3K051760Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05Stereotaxis, Inc.20063—
+4K262744GenesisX RMNStereotaxis, Inc.20260—
+4K183027Steerable catheter control systemStereotaxis, Inc.20192—
+4K122488Amigo Remote Catheter System & AccessoriesCatheter Robotics, Inc.20120—
+4K073225Sensei Catheter Control SystemHansen Medical, Inc.2008241
+5K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc.201911
+5K122275Artisan Extend Control CatheterHansen Medical20120—
+5K090365Hansen Medical Artisan S Control CatheterHansen Medical, Inc.2009221
+6K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc.20200—
+6K141530Vdrive System/ Vdrive Duo/ Vdrive with V-CasStereotaxis, Inc.20141—
+6K091808Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc.2009191
+7K150312Vdrive system, Vdrive Duo, Vdrive with V-SonoStereotaxis, Inc.20150—
+7K120834Corpath 200 SystemCorindus, Inc.20128—
+7K102168Sensei X Robotic Catheter SystemHansen Medical, Inc.2010121
+8K160121CorPath GRX SystemCorindus, Inc.20165—
+8K152999CorPath 200 SystemCorindus, Inc.20162—
+8K150892CorPath 200 SystemCorindus, Inc.20157—
+8K141822Sensei X Robotic Catheter SystemHanson Medical, Inc.201401
+8K111004Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc.2012102
+9K173806CorPath GRX SystemCorindus, Inc.20182—
+9K173288CorPath GRX SystemCorindus, Inc.20181—
+9K132369Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc.201392
+10K202275CorPath GRX SystemCorindus, Inc.20201—
+10K180517CorPath GRX SystemCorindus, Inc.20180—
+10K141614Magellan Robotic SystemHansen Medical201452
+10K133552Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR…Hansen Medical20142—
+11K221464CorPath GRX SystemCorindus, Inc.20220—
+11K151463Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHansen Medical, Inc.20151—
+11K151730Magellan Robotic SystemHansen Medical, Inc.201511
+12K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical, Ltd.20250—
+12K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc.20160—