Navigant 020-004500-37

GUDID M588020004500370

The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The 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.

STEREOTAXIS, INC.

Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software Robotic surgical navigation system application software

• Primary Device ID: M588020004500370
• NIH Device Record Key: 35abae66-7895-4b35-96d4-248472d53aa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigant
• Version Model Number: 5.1.0
• Catalog Number: 020-004500-37
• Company DUNS: 024942265
• Company Name: STEREOTAXIS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M588020004500370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193147

FDA Product Code

• NDQ: System, Catheter Or Guidewire, Steerable (Magnetic)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-03
• Device Publish Date: 2023-04-25

Devices Manufactured by STEREOTAXIS, INC.

• M588020004500370 - Navigant: 2023-05-03The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The 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.
• M588020004500370 - Navigant: 2023-05-03 The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended t
• M588001004115110 - Cardiodrive System: 2022-06-14 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M588001004115120 - Cardiodrive System: 2022-06-14 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M58800100111410 - Hemostasis Adapter: 2021-12-22 Hemostasis Adapter IV Spares, Box, Device Count(5)
• M58800101100010 - Genesis (MNS) with Siemens: 2020-08-28 Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left
• M58800101100030 - Genesis MNS with Model-S: 2020-08-28 "Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left