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510(k) Data Aggregation

    K Number
    K953904
    Device Name
    SARNS 9000 UNIVERSAL ROLLER PUMP
    Manufacturer
    3M HEALTH CARE, LTD.
    Date Cleared
    1996-04-19

    (245 days)

    Product Code
    DWB
    Regulation Number
    870.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M HEALTH CARE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sarns 9000 Universal Roller Pump is indicated for use in extracorporeal circulation of blood for arterial regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
    Device Description
    The Sarns 9000 Universal Roller Pump is a microprocessor controlled 2-roller peristaltic pump with adjustable occlusion. The pump is capable of flows up to 9.99 L/min (depending on pump head tubing used) at pump speeds up to 250 RPM. The Sarns 9000 Universal Roller Pump is dependent on the Sarns 9000 Perfusion System to provide power.
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