Cleared Traditional

K240900 - HOTWIRE™ RF Guidewire (FDA 510(k) Clearance)

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

K240900 · Atraverse Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
30d
Days
Class 2
Risk

K240900 is an FDA 510(k) clearance for the HOTWIRE™ RF Guidewire. Classified as Catheter, Septostomy (product code DXF), Class II - Special Controls.

Submitted by Atraverse Medical (Cardiff By The Sea, US). The FDA issued a Cleared decision on May 1, 2024 after a review of 30 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 devices

Submission Details

510(k) Number K240900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K240900.
SafeSept RF Transseptal Guidewire (SSRF132
K253799 · Pressure Products Medical Device Manufacturing, LLC · Mar 2026
HOTWIRE RF GUIDEWIRE (901XXX)
K260292 · Atraverse Medical · Feb 2026
HOTWIRE RF GUIDEWIRE (901XXX)
K252419 · Atraverse Medical, Inc. · Aug 2025
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