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510(k) Data Aggregation

    K Number
    K020189
    Device Name
    EXEL BUTTERFLY SCALP VEIN SET
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Date Cleared
    2003-03-27

    (433 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K020159
    Why did this record match?
    Reference Devices :

    K020159

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

    EXEL Scalp Vein (butterfly) set is used for administration of IV solution or infusion of medication to the patient via vascular system.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Exel Scalp Butterfly Vein Set." It confirms the device's substantial equivalence to a legally marketed predicate device.

    Crucially, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to AI/algorithm performance.

    The letter is an administrative notice confirming market clearance based on substantial equivalence, not a detailed technical report of device validation.

    Therefore, I cannot provide the requested information from the given text.

    To answer your request, I would need a technical report, a clinical study summary, or a specific performance validation document for the "Exel Scalp Butterfly Vein Set."

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