BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Livewire Electrophysiology Catheter

    K Number: K151617 · Decision Jan 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    69
    Applicant Total
    6
    Review Days
    221

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    Basic Information

    Device Name
    Livewire Electrophysiology Catheter
    K Number
    K151617
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings Inc.(Dba Medline Ren
    Date Received
    June 15, 2015
    Decision Date
    January 22, 2016
    Product Code
    NLH
    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
    NLH Catheter, Recording, Electrode, Reprocessed

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    K193563 Medline ReNewal Reprocessed Harmonic ACE+7 Shears
    K182588 Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
    K170955 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
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