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510(k) Data Aggregation

    K Number
    K102890
    Device Name
    K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
    Manufacturer
    KAWASUMI LABORATORIES AMERICA, INC.
    Date Cleared
    2010-10-21

    (21 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAWASUMI LABORATORIES AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector intended use is for the access of peripheral veins for blood collection. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle. The K-Shield Small Vein Infusion Set with Antineedle Stick Protector intended use is for the access of peripheral veins for solution infusion. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.
    Device Description
    The K-Shield Small Vein Infusion Set with Antineedle Stick Protector and the K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector are sterile, single use devices commonly used to access a patient's veins for blood collection or solution infusion. Both devices are comprised of a needle and wing assembly with tubing and a female luer connector. The Multisample Luer Connector is used to transfer blood from the Winged Collection Set to a vacuum tube. Both devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.
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    K Number
    K030385
    Device Name
    IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
    Manufacturer
    KAWASUMI LABORATORIES AMERICA, INC.
    Date Cleared
    2003-04-15

    (69 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAWASUMI LABORATORIES AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE IV ADD-ON FILTER ADMINISTRATION SET USED TO ATTACH TO A NON FILTERED IV ADMINISTRATION SET FOR THE PURPOSE OF FILTERING SOLUTION DURING INTRAVASCULAR ADMINISTRATION. THE DEVICE MAY INCLUDE A NEELE FREE VALVE INJECTION SITE WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATION AND AIDS IN THE PREVENTION OF NEELDESTICK INJURIES.
    Device Description
    A STERILE, SINGLE USE ADD-ON FILTER ADMINISTRATION SET USED TO SERVE AS A CONDUIT FOR THE FILTRATION OF IV FLUID FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A NEEDLE OR CATHETER INSERTED INTO A VEIN. THE DEVICE MAY INCLUDE A NEELELESS ACCESS CONECTOR WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATION AND AIDS IN THE PREVENTION OF NEELDESTICK INJURIES. THE FILTER PORE SIZE WILL BE .22 OR 1.2 MICRON WITH AN EFFECTIVE FILTRATION RATE (EFA) OF 10 CM2.
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    K Number
    K001423
    Device Name
    KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
    Manufacturer
    KAWASUMI LABORATORIES AMERICA, INC.
    Date Cleared
    2000-07-21

    (77 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAWASUMI LABORATORIES AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001424
    Device Name
    KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
    Manufacturer
    KAWASUMI LABORATORIES AMERICA, INC.
    Date Cleared
    2000-07-21

    (77 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAWASUMI LABORATORIES AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001426
    Device Name
    KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
    Manufacturer
    KAWASUMI LABORATORIES AMERICA, INC.
    Date Cleared
    2000-07-21

    (77 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAWASUMI LABORATORIES AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001043
    Device Name
    KAWASUMI LABORATORY BLOOD DRAWING KIT
    Manufacturer
    KAWASUMI LABORATORIES AMERICA, INC.
    Date Cleared
    2000-05-19

    (49 days)

    Product Code
    KSB
    Regulation Number
    864.9875
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAWASUMI LABORATORIES AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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