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510(k) Data Aggregation

    K Number
    K992999
    Device Name
    DAISY PROTECTED SCALP VEIN SET
    Manufacturer
    DIASOL, INC.
    Date Cleared
    1999-11-05

    (59 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 :

    DAISY PROTECTED SCALP VEIN SET

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

    Provides access to patients vascular system to administer IV fluids Is used in blood drawing Aid in prevention of needlestick injury.

    Device Description

    Daisy Protected Scalp Vein Set

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Daisy Protected Scalp Vein Set." It confirms that the device is substantially equivalent to a predicate device already on the market.

    However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. The letter is a regulatory approval, not a scientific study report. It mentions the "indications for use" for the device, which are:

    • Provides access to patients vascular system to administer IV fluids
    • Is used in blood drawing
    • Aid in prevention of needlestick injury.

    Without the actual 510(k) submission document or a separate study report, I cannot provide the requested details about acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert involvement. The letter itself does not include this information.

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