Cleared Traditional

K252419 - HOTWIRE RF GUIDEWIRE (901XXX) (FDA 510(k) Clearance)

Also includes:
HOTWIRE RF GUIDEWIRE (902XXX)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252419 · Atraverse Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
26d
Days
Class 2
Risk

K252419 is an FDA 510(k) clearance for the HOTWIRE RF GUIDEWIRE (901XXX). Classified as Catheter, Septostomy (product code DXF), Class II - Special Controls.

Submitted by Atraverse Medical, Inc. (Cardiff By The Sea, US). The FDA issued a Cleared decision on August 27, 2025 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5175 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Atraverse Medical, Inc. devices

Submission Details

510(k) Number K252419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DXF Catheter, Septostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXF Catheter, Septostomy

All 19
Devices cleared under the same product code (DXF) and FDA review panel - the closest regulatory comparables to K252419.
SafeSept RF Transseptal Guidewire (SSRF132
K253799 · Pressure Products Medical Device Manufacturing, LLC · Mar 2026
HOTWIRE RF GUIDEWIRE (901XXX)
K260292 · Atraverse Medical · Feb 2026
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
K251007 · Circa Scientific, Inc. · May 2025
Cross Wise™ Multi-Use RF Adapter Cable
K243193 · Circa Scientific, Inc. · Nov 2024
VersaCross™ RF Wire
K242076 · Baylis Medical Company · Nov 2024
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)
K241414 · Circa Scientific, Inc. · Sep 2024