Vdrive System - "The Vdrive® system is intended to stabilize, - STEREOTAXIS, INC.

Duns Number:024942265

Device Description: "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible "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). "

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More Product Details

Catalog Number

001-002307-2

Brand Name

Vdrive System

Version/Model Number

Duo

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

43304fe3-e15f-44ff-a92f-d50c83e2d2f9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STEREOTAXIS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 19