Cardiodrive System 001-004115-11

GUDID M588001004115110

The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.

STEREOTAXIS, INC.

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• Primary Device ID: M588001004115110
• NIH Device Record Key: 0a81a8c3-134e-4c1e-bc49-e7f3de9899a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiodrive System
• Version Model Number: II
• Catalog Number: 001-004115-11
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M588001004115110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071029

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2022-06-14
• Device Publish Date: 2022-06-06

On-Brand Devices [Cardiodrive System]

• M588001004115120: The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatib
• M588001004115110: The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatib