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510(k) Data Aggregation

    K Number
    K992266
    Device Name
    IV ADMINISTRATION SET
    Manufacturer
    NEW ALLIANCE OF INDEPENDENT MEDICAL DISTRIBUTORS,
    Date Cleared
    1999-10-27

    (113 days)

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

    IV administration set used to administer fluids from a container to a patient's venous system through a needle or catheter inserted into a vein.

    Device Description

    Intravenous Administration Set

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an "Intravenous Administration Set" (K992266). It does not contain information about acceptance criteria, device performance studies, or AI/software.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on specific performance data or clinical study results.

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