BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable High-pressure Extension Lines

    K Number: K230668 · Decision Jun 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    1
    Review Days
    462

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    Basic Information

    Device Name
    Disposable High-pressure Extension Lines
    K Number
    K230668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Precision Medical Plastics , Ltd.
    Date Received
    March 10, 2023
    Decision Date
    June 14, 2024
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXT Injector And Syringe, Angiographic

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