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510(k) Data Aggregation

    K Number
    K222182
    Device Name
    Radial Artery Compression Tourniquets
    Manufacturer
    Beijing Demax Medical Technology Co., Ltd.
    Date Cleared
    2023-01-04

    (166 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Radial Artery Compression Tourniquets

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

    The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.

    Device Description

    Radial Artery Compression Tourniquets

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the "Radial Artery Compression Tourniquets" and does not contain the specific information about acceptance criteria, device performance, study details, or AI-related data as requested. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the detailed technical study information you're looking for.

    Therefore, I cannot provide the requested information based on the input text.

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