HOTWIRE™ RF GUIDEWIRE H1S-032-230-ABT-0

GUDID 00850057445053

The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE™ is intended to be used in conjunction with compatible previously cleared intravascular sheaths and/or dilators, and previously cleared RF electrosurgical generator(s). The HOTWIRE™ is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic and/or echogenic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with 3rd party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included Adapter Pin that connects to hand pieces used with compatible previously cleared RF electrosurgical generators.

Atraverse Medical, Inc

Cardiac transseptal access set

• Primary Device ID: 00850057445053
• NIH Device Record Key: a84edb01-cb46-4f41-a287-1b1683584ce9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOTWIRE™ RF GUIDEWIRE
• Version Model Number: 901004
• Catalog Number: H1S-032-230-ABT-0
• 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: 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: +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
• 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	00850057445053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240900

FDA Product Code

• DXF: Catheter, Septostomy

Sterilization

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

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

[00850057445053]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-20
• Device Publish Date: 2025-06-12

On-Brand Devices [HOTWIRE™ RF GUIDEWIRE]

• 00850057445244: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445237: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445220: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445213: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445206: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445190: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445183: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445176: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445169: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445152: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445145: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445138: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445121: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445114: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445107: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445091: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445084: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445077: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445060: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445053: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445046: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445039: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445022: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445015: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power
• 00850057445008: The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power