Cleared Traditional

K251158 - PowerWire® 14 Radiofrequency Guidewire Kit (FDA 510(k) Clearance)

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

K251158 · Baylis Medical Technologies, Inc. · Cardiovascular device
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Sep 2025
Decision
149d
Days
Class 2
Risk

K251158 is an FDA 510(k) clearance for the PowerWire® 14 Radiofrequency Guidewire Kit. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Baylis Medical Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 11, 2025 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Baylis Medical Technologies, Inc. devices

Submission Details

510(k) Number K251158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 15, 2025
Decision Date September 11, 2025
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
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 Peers - PDU Catheter For Crossing Total Occlusions

All 56
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K251158.
Santreva™-ATK Endovascular Revasculariztion Catheter
K252315 · AngioSafe, Inc. · Sep 2025
LimFlow ARC
K251376 · LimFlow, Inc. · May 2025
PowerWire Radiofrequency Guidewire Kit
K232562 · Baylis Medical Technologies, Inc. · Feb 2024
SoundBite® Crossing System XS Peripheral
K230159 · Soundbite Medical Solutions, Inc. · Aug 2023
Tigereye ST CTO-Crossing Catheter
K230594 · Avinger, Inc. · Apr 2023
Tunnel Crossing Catheter
K221163 · Tractus Vascular, LLC · Jan 2023