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

    Excipio LV Prime Thrombectomy Device

    K Number: K251485 · Decision Jun 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    140
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    Excipio LV Prime Thrombectomy Device
    K Number
    K251485
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contego Medical, Inc.
    Date Received
    May 14, 2025
    Decision Date
    June 13, 2025
    Product Code
    QEW
    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
    QEW Peripheral Mechanical Thrombectomy With Aspiration

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    Other Clearances by Contego Medical, Inc.

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