V-Sono Intracardiac Echo Manipulator 001-002469-1

GUDID M58800100246910

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

Stereotaxis, Inc.

Cardiac mapping system workstation

• Primary Device ID: M58800100246910
• NIH Device Record Key: 8a168434-5413-4d7e-8871-cc2da5ae37f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Sono Intracardiac Echo Manipulator
• Version Model Number: 1
• Catalog Number: 001-002469-1
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M58800100246910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122659

FDA Product Code

• DXX: System, Catheter Control, Steerable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-17
• Device Publish Date: 2016-05-02

Devices Manufactured by Stereotaxis, Inc.

• M58800100175110 - QuikCAS Cardiodrive Sterile Components: 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M5880010017711 - QuikCAS Hemostasis Adapter: 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M5880010017712 - Cardiodrive Hemostasis Adapter - SJ: 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M58800100230710 - Vdrive System: 2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
• M58800100230720 - Vdrive System: 2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
• M58800100242210 - V-CAS Catheter Advancement System: 2024-07-17 The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible m
• M58800100245210 - V-Loop Variable Loop Catheter Manipulator: 2024-07-17 The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loo
• M58800100246910 - V-Sono Intracardiac Echo Manipulator: 2024-07-17Vdrive 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
• M58800100246910 - V-Sono Intracardiac Echo Manipulator: 2024-07-17 Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection