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510(k) Data Aggregation

    K Number
    K071269
    Device Name
    HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Date Cleared
    2007-08-01

    (86 days)

    Product Code
    CBT
    Regulation Number
    868.1100
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM

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

    The HemoDraw™ Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided context does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for the HemoDraw™ Arterial Blood Sampling Set, indicating that the device has been found substantially equivalent to a predicate device. It defines the indications for use of the device but does not include any performance data or study design details.

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