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

    VersaD Delivery Catheter

    K Number: K251372 · Decision Oct 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    91
    Applicant Total
    2
    Review Days
    175

    Basic Information

    Device Name
    VersaD Delivery Catheter
    K Number
    K251372
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unity Medical, Inc.
    Date Received
    May 2, 2025
    Decision Date
    October 24, 2025
    Product Code
    QJP
    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
    QJP Catheter, Percutaneous, Neurovasculature

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    Other Clearances by Unity Medical, Inc.

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