Cleared Special

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

K260292 · Atraverse Medical · Cardiovascular
Feb 2026
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K260292 is an FDA 510(k) clearance for the HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX), 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 February 27, 2026, 29 days after receiving the submission on January 29, 2026. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K260292 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2026
Decision Date February 27, 2026
Days to Decision 29 days
Submission Type Special
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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