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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
    Why did this record match?
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    Matched: '868.1100'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K070340
    Device Name
    SECURE ARTERIAL BLOOD SAMPLING SYSTEM
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Date Cleared
    2007-03-15

    (37 days)

    Product Code
    CBT
    Regulation Number
    868.1100
    Why did this record match?
    Search-Everything :

    Matched: '868.1100'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SECURE® 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
    The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system.
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