Other products from "STEREOTAXIS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 M58800101005611 1 001-010056-1 "The Vdrive® system is intended to stabilize, navigate and remotely control: • C "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). " DXX,DQX System, Catheter Control, Steerable,Wire, Guide, Catheter Vdrive Drape
2 M58800100245210 1 001-002452-1 The Vdrive with V-Loop disposable is indicated to remotely control the advanceme The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatibile loop catheters inserted across the septum into the left atrium using conventional procedures DXX,DQX System, Catheter Control, Steerable,Wire, Guide, Catheter 2 V-Loop Variable Loop Catheter Manipulator
3 M5880010017711 1 001-001771-1 The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. DQX Wire, Guide, Catheter QuikCAS Hemostasis Adapter
4 M58800100784010 Studio 001-007840-1 The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab OUG Medical Device Data System 1 Odyssey Cinema
5 M58800100246910 1 001-002469-1 Vdrive with V-Sono is indicated for remotely controlling the advancement, retrac Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium DXX,DQX System, Catheter Control, Steerable,Wire, Guide, Catheter 2 V-Sono Intracardiac Echo Manipulator
6 M58800100701020 Quad HD 001-007010-2 The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab DXX System, Catheter Control, Steerable 2 Odyssey
7 M58800100790010 Link 001-007900-1 The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab OUG Medical Device Data System 1 Odyssey
8 M58800100242210 1 001-002422-1 The Vdrive with V-CAS Disposable is indicated for remotely controlling the advan The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System DXX,DQX System, Catheter Control, Steerable,Wire, Guide, Catheter 2 V-CAS Catheter Advancement System
9 M588020004500360 5.0.7 020-004500-36 The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigat The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS. NDQ System, Catheter Or Guidewire, Steerable (Magnetic) 2 Navigant
10 M588020004500260 5.0.2 020-004500-26 The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe M The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS NDQ System, Catheter Or Guidewire, Steerable (Magnetic) 2 Navigant
11 M588020004500220 4.6.5 020-004500-22 The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe M The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS NDQ System, Catheter Or Guidewire, Steerable (Magnetic) 2 Navigant
12 M588020004500210 4.6.4 020-004500-21 The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe M The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS NDQ System, Catheter Or Guidewire, Steerable (Magnetic) 2 Navigant
13 M58800100230720 Duo 001-002307-2 "The Vdrive® system is intended to stabilize, navigate and remotely control: • C "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). " DXX,DQX System, Catheter Control, Steerable,Wire, Guide, Catheter 2 Vdrive System
14 M58800100610010 ES Philips 001-006100-1 Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Work Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction NDQ System, Catheter Or Guidewire, Steerable (Magnetic) 2 Niobe MNS Philips
15 M58800100230710 Single Arm 001-002307-1 "The Vdrive® system is intended to stabilize, navigate and remotely control: • C "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). " DXX,DQX System, Catheter Control, Steerable,Wire, Guide, Catheter 2 Vdrive System
16 M58800100175110 1 001-001751-1 The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. DQX Wire, Guide, Catheter 2 QuikCAS Cardiodrive Sterile Components
17 M58800100411590 II 001-004115-9 The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. DQX Wire, Guide, Catheter 2 Cardiodrive System
18 M588001004115120 II 001-004115-12 The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. DQX Wire, Guide, Catheter 2 Cardiodrive System
19 M588001004115110 II 001-004115-11 The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. DQX Wire, Guide, Catheter 2 Cardiodrive System
20 M58800100111411 IV-1 0010011141 Hemostasis Adapter IV Spares, Box, Device Count(5) DQX Wire, Guide, Catheter 2 Hemostasis Adapter
21 M58800100600010 ES Siemens 001-006000-1 Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Work Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction NDQ System, Catheter Or Guidewire, Steerable (Magnetic) 2 Niobe MNS Siemens
22 M5880010017712 1 001-001771-2 The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. DQX Wire, Guide, Catheter Cardiodrive Hemostasis Adapter - SJ
23 M58800101100010 1.1 Siemens 001-011000-1 Genesis MNS is intended to navigate compatible magnetic devices through tissue t Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right andleft heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desireddirection. PJB,NDQ Catheter Remote Control System,System, Catheter Or Guidewire, Steerable (Magnetic) 2 Genesis (MNS) with Siemens
24 M58800101100030 1.1 Model-S 001-011000-3 "Genesis MNS is intended to navigate compatible magnetic devices through tissue "Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right andleft heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desireddirection. " PJB,NDQ Catheter Remote Control System,System, Catheter Or Guidewire, Steerable (Magnetic) 2 Genesis MNS with Model-S
25 M58800100781010 EIF 001-007810-1 The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab OUG Medical Device Data System 1 Odyssey Enterprise Interface
26 M58800100591011 1 001-005910-1 Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Work Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction NDQ System, Catheter Or Guidewire, Steerable (Magnetic) Niobe Cover Drape
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