Cleared Traditional

HOTWIRE? RF Guidewire

K240900 · Atraverse Medical · Cardiovascular
May 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K240900 is an FDA 510(k) clearance for the HOTWIRE? RF Guidewire, a Catheter, Septostomy (Class II — Special Controls, product code DXF), submitted by Atraverse Medical (Cardiff By The Sea, US). The FDA issued a Cleared decision on May 1, 2024, 30 days after receiving the submission on April 1, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K240900 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2024
Decision Date May 01, 2024
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXF — Catheter, Septostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5175

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