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510(k) Data Aggregation

    K Number
    K131517
    Device Name
    MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
    Manufacturer
    MEDRAD, INC. / BAYER MEDICAL CARE, INC.
    Date Cleared
    2013-08-02

    (66 days)

    Product Code
    FPK, CLA
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    FPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.
    Device Description
    The MEDRAD Twist & Go High Pressure Connector Tubing is a sterile, single-use only, disposable connector tube that is used to transfer contrast media and common flushing solutions from an automated injector syringe to an administration set during angiographic procedures.
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    K Number
    K063114
    Device Name
    DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
    Manufacturer
    COEUR, INC.
    Date Cleared
    2007-02-09

    (121 days)

    Product Code
    FPK, FPA
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    FPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe
    Device Description
    The Disposable Transfer Sets with and without Swabbable Valves and/or Check Valves are a combination of connectors and accessories, such as clamps, tubing, and spikes, and are used for fluid delivery. The device is designed, like other legally marketed devices, for one end to connect to the syringe to be filled (which is installed on an injector with the plunger forward) and the other end is connected to the bulk container. The plunger is then retracted and contrast, saline, or other diagnostic fluid is drawn into the syringe.
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    K Number
    K063239
    Device Name
    LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
    Manufacturer
    HOSPIRA, INC.
    Date Cleared
    2006-12-11

    (46 days)

    Product Code
    FPK, FPA
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    FPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.
    Device Description
    The LifeShield® Latex-Free GraviTech™ Flow Controller !.V. Set will consist of variations of the following components: non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut off devices, integral CLAVE® ports or prepierced injection sites, backcheck valves, semi-rigid adapters, male adapter and air filter assembly. The GraviTech™ device provides a manual flow control with head height compensation to the LifeShield® product line.
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    K Number
    K052431
    Device Name
    MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
    Manufacturer
    MEDTRONIC MINIMED
    Date Cleared
    2005-11-29

    (84 days)

    Product Code
    FPK
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    FPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic MiniMed Leapfrog II Infusion Set is indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.
    Device Description
    The Medtronic MiniMed® Leapfrog II Infusion Sct. models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2, are single use infusion administration sets intended for use with an external infusion pump, such as the Medtronic MiniMed® infusion pump. The infusion administration set attaches proximally to a medication reservoir by means of a female Luer connector and is inserted into the subcutancous tissue of the user distally through an indwelling catheter made of Fluorinated Ethylene (FEP). Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion. The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.
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    K Number
    K041178
    Device Name
    EMPOWER TRANSFER SET, (CAT. NO. 7725)
    Manufacturer
    E-Z-EM, INC.
    Date Cleared
    2004-07-16

    (72 days)

    Product Code
    FPK
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    FPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.
    Device Description
    The Empower Transfer Set is a disposable set used to transfer contrast media or saline from a container that can be spiked to a CT power Injector syringe.
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    K Number
    K031808
    Device Name
    MEDRAD SWABBABLE VALVE TRANSFER SET
    Manufacturer
    MEDRAD, INC.
    Date Cleared
    2003-07-11

    (29 days)

    Product Code
    FPK, FPA
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    FPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.
    Device Description
    The Medrad Swabbable Valve Transfer Set (SVTS) is a modified Medrad Transfer Set (K022431). The SVTS is a medical disposable device used to transfer contrast media and saline from a spikeable container to a power injector syringe. The SVTS is works in conjunction with the MR-CT Fill Station, and facilitates the delivery of contrast agent and/or saline into a syringe.
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    K Number
    K022431
    Device Name
    MEDRAD TRANSFER SET
    Manufacturer
    MEDRAD, INC.
    Date Cleared
    2002-09-05

    (42 days)

    Product Code
    FPK, LHI
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    FPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.
    Device Description
    The Medrad Transfer Set is medical disposable device used to transfer intravascular contrast media and saline from a spikeable container to a power injector syringe. The device components consist of a vented spike, connector tube, a means of manually stopping flow, female luer, and individually packaged sterile caps.
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    K Number
    K965208
    Device Name
    POLYFIN EXTENSION SET, MODELS 126 AND 128
    Manufacturer
    MEDTRONIC MINIMED
    Date Cleared
    1997-02-26

    (61 days)

    Product Code
    FPK
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    FPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polyfin extension set is intended for use as a fluid delivery set for medication from an external infusion pump.
    Device Description
    The new device is a 42 inch or 60 inch length of Polyfin® with Luer connectors at each end. The device at the proximal end to a medication reservoir, such as the MiniMed reservoir, model 103, and at the distal end to an infusion set such as the Polyfin infusion set, model 106. The Polyfin extension set may also be used to administer drugs labeled for intravenous administration from an external pump by attaching the distal end to a "Y-site" or "Heparin lock."
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