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510(k) Data Aggregation

    K Number
    K103736
    Device Name
    DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE
    Manufacturer
    DMC MEDICAL LTD.
    Date Cleared
    2011-06-10

    (170 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMC MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DMC Medical piston type syringes are single use syringes intended for injecting fluids into or withdrawing fluids from the body.
    Device Description
    DMC Medical Single-Use Polycarbonate Syringe is offered in the same configurations as the predicate. It is made from a calibrated hollow barrel, and a moveable piston with a plunger tip at the end of the piston. The piston shaft does not contact any part of the fluid path, rather the tip which attaches to the shaft and the barrel are fluid path components. Individual components are made from properly tested materials included in this submission. Additionally, there is a small amount of lubricant for moving the piston shaft smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals.
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    K Number
    K992932
    Device Name
    CIPA (ADULTS) CIPI (INFANTS)
    Manufacturer
    DMC MEDICAL LTD.
    Date Cleared
    2000-06-07

    (281 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMC MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The cardiac insulation pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the mvocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.
    Device Description
    The Cardiac Insulation Pad is a thin, pliable, foam pad which can be cut to conform to the shape of the heart. The pad covers the posterior cardiac wall or the mvocardium. When the surgeon is finished using the pad, it can be easily removed by pulling the PVC locator tape. The cardiac pad is available in two sizes; adult and infant. The Cardiac Insulation Pad isolates the myocardium from warmer tissues (descending thoracic aorta, liver, and surrounding pericardial tissues) and thus reduces undesirable re-warming of the myocardium. In addition, it protects the left phrenic nerve from cold injury during local cooling of the heart. Material: Crosslinked, closed cell polyolefin foam
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    K Number
    K000704
    Device Name
    DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
    Manufacturer
    DMC MEDICAL LTD.
    Date Cleared
    2000-05-19

    (78 days)

    Product Code
    GBX
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMC MEDICAL LTD.

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