Navigant - The Navigant Navigation Workstation is a - STEREOTAXIS, INC.

Duns Number:024942265

Device Description: The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NW 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

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More Product Details

Catalog Number

020-004500-21

Brand Name

Navigant

Version/Model Number

4.6.4

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

K060967

Product Code Details

Product Code

NDQ

Product Code Name

System, Catheter Or Guidewire, Steerable (Magnetic)

Device Record Status

Public Device Record Key

f3b38b46-4e99-4b75-ab5f-1700b1c57b01

Public Version Date

July 06, 2018

Public Version Number

3

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