HOTWIRE™ RF GUIDEWIRE

Basic Information

Brand Name: HOTWIRE™ RF GUIDEWIRE
Primary DI: 00850057445596
Version / Model: 902034
Catalog Number: H2S-035-230-0
Company Name: Atraverse Medical, Inc
Labeler DUNS: 118954537
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-10-02
Public Version: 2
Public Version Date: 2026-03-20
Public Version Status: Update
Public Device Record Key: 57394dc0-a846-4bb3-bc6c-c9264d522e55

Device Description

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 with the HOTWIRE™ System RF Generator. 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 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 third-party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for connection to the included Handpiece, which connects to the Hotwire System RF Generator.

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: Yes
Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXF	Catheter, Septostomy	Cardiovascular	870.5175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47247	Cardiac transseptal access set	A collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850057445596	GS1

Customer Contacts

Phone: +1 760-278-8098
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Guidewire Diameter	.035	Inch
Guidewire Length	230	Centimeter

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -30 – 60 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 15 – 90 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 80 – 109 KiloPascal