Cleared Traditional

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

K252419 · Atraverse Medical, Inc. · Cardiovascular

Aug 2025

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K252419 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, Inc. (Cardiff By The Sea, US). The FDA issued a Cleared decision on August 27, 2025, 26 days after receiving the submission on August 1, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number	K252419 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2025
Decision Date	August 27, 2025
Days to Decision	26 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF