BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    pNOVUS 21 Microcatheter

    K Number: K242420 · Decision Nov 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    3
    Review Days
    89

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    Basic Information

    Device Name
    pNOVUS 21 Microcatheter
    K Number
    K242420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phenox, Ltd.
    Date Received
    August 15, 2024
    Decision Date
    November 12, 2024
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Phenox, Ltd.

    K Number Device Name
    K251357 Esperance pHLO Aspiration System
    K221279 pNOVUS 21 Microcatheter