Address:710 N. Tucker Blvd., Suite 110,Saint Louis,MO,63101,US
Device Description : Hemostasis Adapter IV Spares, Box, Device Count(5)
Device Class : 2
Duns Number: 024942265
Premarket Exempt : No
Prescription Use : Yes
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
Prescription Use : Yes
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 :
Duns Number: 024942265
Premarket Exempt : No
Prescription Use : Yes
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 :
Duns Number: 024942265
Premarket Exempt : No
Prescription Use : Yes
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 : 2
Duns Number: 024942265
Premarket Exempt : No
Prescription Use : Yes
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 : 2
Duns Number: 024942265
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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
Device Class : 2
Duns Number: 024942265
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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
Device Class : 2
Duns Number: 024942265
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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
Device Class : 2
Duns Number: 024942265
Premarket Exempt : No
Prescription Use : Yes
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
Prescription Use : Yes