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510(k) Data Aggregation

    K Number
    K251158
    Device Name
    PowerWire® 14 Radiofrequency Guidewire Kit
    Manufacturer
    Baylis Medical Technologies Inc.
    Date Cleared
    2025-09-11

    (149 days)

    Product Code
    PDU
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K230571,K122278,K232562
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PowerWire® 14 Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater, including vessels with stents.

    Device Description

    PowerWire 14 Radiofrequency Guidewire is a sterile, single-use device used to deliver radiofrequency (RF) energy. It is shipped as a sterile device kit containing one (1) PowerWire 14 RF Guidewire and one (1) RFP-100A Connector Cable (separately cleared under K230571) sealed in a double compartment pouch, which is then placed inside a shelf box and then an outer cardboard box. The device is sterilized using ethylene oxide.

    The device consists of a core wire surrounded by a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable (K230571) and has an active tip at the distal end to deliver radiofrequency energy.

    The PowerWire 14 Radiofrequency Guidewire must be used with a cleared generator such as the Baylis Radiofrequency Puncture Generator (Baylis RF Generator K122278) and connector cable such as RFP-100A Connector Cable (K230571). The connector cable connects the generator to the PowerWire 14 RF Guidewire to enable RF energy to be delivered from the Generator to the PowerWire 14 RF Guidewire.

    The PowerWire 14 Radiofrequency Guidewire delivers RF energy in a monopolar mode between its distal electrode and a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrode.

    The PowerWire 14 Radiofrequency Guidewire is available in both a 190 cm and 300 cm length with an outside diameter of 0.014". Each length is available in both straight and angled distal configurations which provide physicians with flexibility of choosing the most suitable guidewire for accessing target tissue in tortuous pathways in the body, with either straight or angled distal tips.

    Once the occlusion is crossed, the PowerWire 14 Radiofrequency Guidewire can act as a rail for balloon catheters, or can be exchanged for other guidewires or devices cleared for peripheral interventional procedures. The PowerWire 14 Radiofrequency Guidewire is designed to be compatible with balloon catheters approved for use in peripheral interventional procedures.

    AI/ML Overview

    N/A

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