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

    Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

    K Number: K212165 · Decision Mar 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    40
    Review Days
    241

    Basic Information

    Device Name
    Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
    K Number
    K212165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovative Health, LLC.
    Date Received
    July 12, 2021
    Decision Date
    March 10, 2022
    Product Code
    PNE
    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
    PNE Reprocessed Catheter Introducer

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