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510(k) Data Aggregation

    K Number
    K013714
    Device Name
    CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP
    Manufacturer
    CODAN US CORP.
    Date Cleared
    2002-03-28

    (140 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CODAN IV Administration Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding an I.V. Administration Set. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to legally marketed predicate devices, not on the performance metrics of the device itself.

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