# Atraverse Medical Secures FDA 510(k) Clearance for Fully Integrated HOTWIRE Transseptal Access System

> fda · REPORTED · 2025-12-04

Atraverse Medical received FDA 510(k) clearance for its fully integrated HOTWIRE Transseptal Access System, including the HOTWIRE RF Generator featuring impedance-guided shutoff after transseptal crossing to mitigate the risk of uncontrolled energy delivery. The cleared HOTWIRE RF Guidewire had been used successfully in nearly 2,000 clinical procedures at the time of clearance.

About Atraverse Medical: Atraverse Medical is a San Diego-based medtech company developing next-generation left-heart access technology, with its proprietary HOTWIRE radiofrequency guidewire designed to enable zero-exchange transseptal access for cardiovascular procedures.

- Company: Atraverse Medical
- Sector: all
- Primary source: https://www.prnewswire.com/news-releases/atraverse-medical-secures-fda-510k-clearance-for-hotwire-rf-generator--fully-integrated-transseptal-access-system-302631993.html

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.