Cleared Traditional

PowerWire? 14 Radiofrequency Guidewire Kit

K251158 · Baylis Medical Technologies, Inc. · Cardiovascular

Sep 2025

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K251158 is an FDA 510(k) clearance for the PowerWire? 14 Radiofrequency Guidewire Kit, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by Baylis Medical Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 11, 2025, 149 days after receiving the submission on April 15, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K251158 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PDU — Catheter For Crossing Total Occlusions
Device Class	Class II — 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.