Manufacturer
Atraverse Medical, Inc.HOTWIRE™ System RF Generator and Footswitch (optional accessory)
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252083
- Device name
- HOTWIRE™ System RF Generator and Footswitch (optional accessory)
- Company
- Atraverse Medical, Inc.
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-07-02
- Decision date
- 2025-08-12
- Submission type
- Traditional
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The HOTWIRE™ System RF Generator and Footswitch (optional accessory) is to be used with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect.
Intended Use
The HOTWIRETM System RF Generator and Footswitch (optional accessory) is to be used with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect.
Device Description
The HOTWIRETM System RF Generator is an AC mains power-operated device used with compatible, separately cleared RF device (i.e., HOTWIRETM RF guidewire - K240900) which are connected to the RF Generator through a HOTWIRETM System Handpiece. The RF Generator delivers power in a monopolar mode between the distal tip electrode and a commercially available patient return electrode such as the Valleylabs Patient Return Electrode Model #E7507 (K822572). An optional HOTWIRETM System Footswitch may be used with the RF Generator. The HOTWIRETM System RF Generator is used with HOTWIRETM RF Guidewire in transseptal surgical procedures to puncture the fossa ovalis and gain access from the right side of the heart to the left atrium. The RF Generator is used to provide RF energy through the HOTWIRETM System Handpiece and into the RF Guidewire to facilitate the septal puncture.
Summary parsed at:2026-06-20 17:50:03 UTC