Vdrive System 001-002307-2

GUDID M58800100230720

"The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance 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 of electrophysiological 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 used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS). "

Stereotaxis, Inc.

Cardiac mapping system workstation
Primary Device IDM58800100230720
NIH Device Record Key43304fe3-e15f-44ff-a92f-d50c83e2d2f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVdrive System
Version Model NumberDuo
Catalog Number001-002307-2
Company DUNS024942265
Company NameStereotaxis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM58800100230720 [Primary]

FDA Product Code

DXXSystem, Catheter Control, Steerable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-07-17
Device Publish Date2016-08-01

On-Brand Devices [Vdrive System]

M58800100230720"The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible In
M58800100230710"The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible In
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.