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510(k) Data Aggregation

    K Number
    K000343
    Device Name
    NAC Y-ADP
    Manufacturer
    THE KIPP GROUP
    Date Cleared
    2000-03-01

    (27 days)

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

    THE KIPP GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000152
    Device Name
    KIPPMED I.V. MANIFOLD
    Manufacturer
    THE KIPP GROUP
    Date Cleared
    2000-02-29

    (41 days)

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

    THE KIPP GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993147
    Device Name
    DECAP
    Manufacturer
    THE KIPP GROUP
    Date Cleared
    1999-11-02

    (42 days)

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

    THE KIPP GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DECap™ is a non-vented cap that is intended to seal male or female luer locks that are part of typical medical devices such as manifolds, stopcocks or sets.
    Device Description
    The DECap™ is a non-vented cap.
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    K Number
    K992268
    Device Name
    NAC PRN NEEDLELESS ACCESS CONNECTOR
    Manufacturer
    THE KIPP GROUP
    Date Cleared
    1999-09-15

    (71 days)

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

    THE KIPP GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NAC PRN Needleless Access Connector is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.
    Device Description
    Not Found
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    K Number
    K991932
    Device Name
    INTRAVASCULAR ADMINISTRATION SET
    Manufacturer
    THE KIPP GROUP
    Date Cleared
    1999-08-20

    (73 days)

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

    THE KIPP GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container, an infusion line filter, a 2 or 3 port manifold or I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.
    Device Description
    Intravascular Administration Set/Extension Set
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    K Number
    K970255
    Device Name
    KIPP MED I.V. MANIFOLD
    Manufacturer
    THE KIPP GROUP
    Date Cleared
    1997-04-14

    (82 days)

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

    THE KIPP GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used as a conduit for the delivery of I.V. fluids from a container to a patient's vascular system through a needle or cather inserted into a vein. Additionally, this device is intended to serve as an injection site for other influsion fluids. This device is intended to be used only by trained professionals in a clinical or hospital environment.
    Device Description
    The KippMed I.V. Manifold is substantially equivalent to the Braun Safesite Manifold, Minor differences in design specifications have been listed in Table One. Both devices are intended to provide connections to an I.V. Administration Set. Both devices provide a multi-port connector with a female leur-lock adapter, three normally closed backcheck valves and a connection adapter. The inlet connection adapter for both devices includes a free-spinsing hub/leur lock to connect to I.V. lines. Both devices are sterile and nonpyrogenic.
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