STEREOTAXIS, INC.

Address:710 N. Tucker Blvd., Suite 110,Saint Louis,MO,63101,US

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- Catalog Number : 001-004115-12

Device Description : 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.

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

- Catalog Number : 001-004115-9

Device Description : 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.

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

- Catalog Number : 001-005910-1

Device Description : 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

Device Class :

Duns Number: 024942265

Premarket Exempt : No

Product Code : NDQ

Prescription Use : Yes

Device Count : 10

- Catalog Number : 001-006000-1

Device Description : 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

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : NDQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 001-006100-1

Device Description : 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

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : NDQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 001-007010-2

Device Description : 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

Device Class : 2

Duns Number: 024942265

Premarket Exempt : No

Product Code : DXX

Prescription Use : Yes

Device Count : 1

- Catalog Number : 001-007810-1

Device Description : 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

Device Class : 1

Duns Number: 024942265

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 001-007840-1

Device Description : 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

Device Class : 1

Duns Number: 024942265

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 001-007900-1

Device Description : 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

Device Class : 1

Duns Number: 024942265

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 001-010056-1

Device Description : "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). "

Device Class :

Duns Number: 024942265

Premarket Exempt : No

Product Code : DXX, DQX

Prescription Use : Yes

Device Count : 10