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510(k) Data Aggregation

    K Number
    K960486
    Device Name
    KSEA MODEL 383320 20 ANGIOMAT
    Date Cleared
    1996-10-25

    (266 days)

    Product Code
    Regulation Number
    870.1800
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    Product Code :

    DQI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KSEA model 38320 20 Angiomat pump is designed to provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system. Please consult your angloscope manual for specific indications and contraindications for use.
    Device Description
    The KSEA model 383320 20 Angiomat for endoscopy of the peripheral vascular system is a microprocessor-based infusion pump, with user adjustable flow rates and pressure adjustment. The unit incorporates a wide variety of safety features including: bubble detection, pressure monitoring, volume monitoring and flow control. The Angiomat has two operating modes and also incorporates a bolus infusion function.
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