HOTWIRE™ System Footswitch FS1

GUDID 00850057445626

Atraverse Medical, Inc

Foot-switch, electrical

• Primary Device ID: 00850057445626
• NIH Device Record Key: 29870d00-1558-4d71-8a91-6fa1b9711b20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOTWIRE™ System Footswitch
• Version Model Number: 905001
• Catalog Number: FS1
• Company DUNS: 118954537
• Company Name: Atraverse Medical, 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: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1 760-278-8098
• Email: info@atraversemedical.com
• Phone: +1 760-278-8098
• Email: info@atraversemedical.com
• Phone: +1 760-278-8098
• Email: info@atraversemedical.com
• Phone: +1 760-278-8098
• Email: info@atraversemedical.com
• Phone: +1 760-278-8098
• Email: info@atraversemedical.com
• Phone: +1 760-278-8098
• Email: info@atraversemedical.com
• Phone: +1 760-278-8098
• Email: info@atraversemedical.com
• Phone: +1 760-278-8098
• Email: info@atraversemedical.com
• Phone: +1 760-278-8098
• Email: info@atraversemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850057445626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252083

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2025-09-17
• Device Publish Date: 2025-09-09

Devices Manufactured by Atraverse Medical, Inc

• 00850057445268 - HOTWIRE™ RF GUIDEWIRE: 2025-10-06 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445251 - HOTWIRE™ System RF Generator: 2025-09-17 The HOTWIRE™ System RF Generator is an AC mains power-operated device used with compatible, separately cleared RF puncture dev
• 00850057445626 - HOTWIRE™ System Footswitch: 2025-09-17
• 00850057445626 - HOTWIRE™ System Footswitch: 2025-09-17
• 00850057445008 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445015 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445022 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445039 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal
• 00850057445046 - HOTWIRE™ RF GUIDEWIRE: 2025-06-20 The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal