Hotwire™ Rf Guidewire

FDA UDI

Class II (US FDA UDI)

by Atraverse Medical

Identity

Trade Name: HOTWIRE™ RF GUIDEWIRE FDA UDI
Generic Name: Cardiac transseptal access set FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 901016 FDA UDI
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 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. FDA UDI

Identifiers

Catalog Number: H1S-035-230-MDT-0 FDA UDI
Primary DI / UDI-DI: 00850057445169 FDA UDI
510(k) Number: K240900 FDA UDI
FDA Product Code: DXF FDA UDI
GMDN Term: Cardiac transseptal access set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5175 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Cardiac transseptal access set

Hotwire™ Rf Guidewire by Atraverse Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac transseptal access set.

VersaCross Steerable Access Solution — Baylis Médicale Cie Inc · Class II
VersaCross Steerable Access Solution — Baylis Médicale Cie Inc · Class II
Cook — COOK INCORPORATED · Class II
HeartSpan® — Merit Medical · Class II
HeartSpan® — Merit Medical · Class II
Cook — COOK INCORPORATED · Class II
PathBuilder Transseptal Guiding Introducer — Shanghai Microport Ep Medtech Co., Ltd. · Class II
VersaCross™ Access Solution — Baylis Médicale Cie Inc · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Atraverse Medical

Sources (1)

FDA UDI ae061c69-cf9f-48bb-8552-13d2ff151b07 36 fields · synced Jun 1, 2026