BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    VasQ

    K Number: DEN220026 · Decision Sep 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    515

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    Basic Information

    Device Name
    VasQ
    K Number
    DEN220026
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.4600
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Laminate Medical Technologies , Ltd.
    Date Received
    April 29, 2022
    Decision Date
    September 26, 2023
    Product Code
    QVQ
    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
    QVQ Extravascular Support For An Arteriovenous Fistula For Vascular Access

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QVQ), ordered by most recent decision date.

    VasQ

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Laminate Medical Technologies , Ltd.

    K Number Device Name
    K240119 VasQ