BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

    PowerWire Radiofrequency Guidewire Kit

    K Number: K232562 · Decision Feb 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    56
    Applicant Total
    5
    Review Days
    188

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    Basic Information

    Device Name
    PowerWire Radiofrequency Guidewire Kit
    K Number
    K232562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Baylis Medical Technologies, Inc.
    Date Received
    August 24, 2023
    Decision Date
    February 28, 2024
    Product Code
    PDU
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PDU Catheter For Crossing Total Occlusions

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    Other Clearances by Baylis Medical Technologies, Inc.

    K Number Device Name
    K254114 Baylis Connector Cable
    K250275 PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
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    K230571 RFP-100A Connector Cable (Single Use)