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510(k) Data Aggregation

    K Number
    K993518
    Device Name
    MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL
    Manufacturer
    MEDEFIL, INC.
    Date Cleared
    2000-06-12

    (238 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDEFIL'S HEPARIN I.V.
    FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL

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

    FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)

    Device Description

    Sterile Heparin I. V. Flush Syringe

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device: "Medefil's Heparin I.V. Flush Syringe". It grants permission to market the device based on its substantial equivalence to a legally marketed predicate device.

    Therefore, this document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory approval document, not a scientific study report.

    The request asks for specific details about acceptance criteria, device performance, study design (sample sizes, data provenance, expert involvement, adjudication), MRMC studies, standalone performance, ground truth establishment, and training set information. None of this information is present in the provided text.

    To answer your request, you would need a scientific or clinical study report for the "Medefil's Heparin I.V. Flush Syringe", not this FDA clearance letter.

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