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510(k) Data Aggregation

    K Number
    K043328
    Device Name
    MICROFLO-SAFE SCALP VEIN SET
    Manufacturer
    DKS LOVERSAN INDUSTRIA BIOMEDICA SPA
    Date Cleared
    2005-04-15

    (134 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K031279,K000592,K000714
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

    Device Description

    The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

    AI/ML Overview

    This is a description of a medical device 510(k) premarket notification for the "MICROFLO-SAFE Scalp Vein Set." As such, it details the intended use and classification of the device, rather than a clinical study evaluating its performance against specific acceptance criteria.

    The information provided does not contain the specific details required to answer your questions regarding acceptance criteria, device performance, study types, sample sizes, ground truth establishment, or expert qualifications. This document is a regulatory filing, not a clinical study report.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria, an MRMC study, or a standalone study based on the provided text. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

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