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510(k) Data Aggregation

    K Number
    K211078
    Device Name
    Progreat Lambda
    Date Cleared
    2021-12-21

    (253 days)

    Product Code
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Terumo Clinical Supply Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Progreat Lambda is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intra-arterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels.
    Device Description
    Progreat Lambda is a single use, ethylene oxide sterilized device that is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intra-arterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels. The catheter consists of metal wire mesh reinforced multi-layer polymer tubing. The mesh is embedded in the catheter wall the entire length of the catheter with the exception of the distal tip section. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer with the exception of the proximal end that is 60cm from the catheter hub. The coating becomes lubricious when wet with saline solution or blood. The device is offered in effective lengths of 110, 130, 150, 165 and 175 cm.
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