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510(k) Data Aggregation

    K Number
    K033301
    Device Name
    IV ADMINISTRATION AND CONNECT SETS
    Manufacturer
    CODAN US CORP.
    Date Cleared
    2004-03-04

    (142 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 :

    IV ADMINISTRATION AND CONNECT SETS

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

    CODAN US IV Administration sets, In-line sets and Connect Sets are indicated for use to facilitate the continuous and bolus infusion of IV fluids, pain control includes in the systems.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to CODAN US Corporation regarding their "IV Administration and Connect Sets." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a detailed study as that information is not present in the provided text.

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