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510(k) Data Aggregation

    K Number
    K020533
    Device Name
    EXEL VACULET BLOOD COLLECTION SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2002-12-02

    (286 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K151991
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is an integral part of blood collection (intravenously) used in connection with luer adapter for collection of whole blood into tubes.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the "EXEL Vaculet Blood Collection Set". It is an administrative document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot fulfill your request based on the provided text. The document confirms that the device is substantially equivalent to a predicate device, which is a regulatory determination, not a performance study.

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