BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    ProtekDilate Vascular Access Kit

    K Number: K253616 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    103
    Applicant Total
    61
    Review Days
    31

    Basic Information

    Device Name
    ProtekDilate Vascular Access Kit
    K Number
    K253616
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Italia S.R.L.
    Date Received
    November 18, 2025
    Decision Date
    December 19, 2025
    Product Code
    DRE
    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
    DRE Dilator, Vessel, For Percutaneous Catheterization

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