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510(k) Data Aggregation

    K Number
    K973237
    Device Name
    CSS-CARDIOPLEGIA SAFETY SYSTEM
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Date Cleared
    1998-04-27

    (242 days)

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

    MEDTRONIC BIO-MEDICUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.
    Device Description
    The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument and disposable Cardioplegia Sets. The instrument delivers cardioplegia solution through dual peristaltic independently operated pumps (one for blood, one for crystalloid). It monitors volume delivered, flow rate (adjustable from 0 - 990 ml/min), and pressure (line and external). It also includes temperature monitoring capabilities, gross air detection using ultrasonic technology, and two independent elapsed timers. The instrument has a color central information display and a two-stage alert-alarm process. It has battery backup for 60 minutes of "On" time and 15 minutes of pumping time. The disposable sets are single use, sterile, and nonpyrogenic, designed to mix arterial blood and asanguineous cardioplegia solution at various ratios. The sets include silicone tubing and polycarbonate connectors and are available in four configurations, with or without a heat exchanger and with standard or dual lumen patient lines.
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    K Number
    K973011
    Device Name
    BPX80 BIO-PUMP (BPX80)
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Date Cleared
    1998-02-25

    (196 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC BIO-MEDICUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic Bio-Medicus Bio-Pump centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
    Device Description
    The BPX-80 Bio-Pump centrifugal blood pump is a single use, disposable, non-pyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force created by smooth rotating cones. Venous blood gravity drains into the inlet port of the Bio-Pump". The smooth cones rotate in the polycarbonate housing. As the cones rotate, energy in the form of pressure and velocity is transferred from the cones to the blood is gently accelerated toward the outlet of the pump. The Bio-Pump moves the blood through the circuit at a desired pressure and flow rate by increasing the speed of the rotating cones. This is accomplished by adjusting the Bio-Console's RPMs (revolutions per minute). Arterial blood is returned to the patient from the extracorporeal circuit. The BPX-80 Bio-Pump consists of a housing and backplate, three smooth surface cones, a magnet, and a bearing/shaft assembly. The plastic components of the BPX-80 Bio-Pump are molded from polycarbonate. The joints are bonded with an ultraviolet light cured adhesive. The inlet port (3/8") is located at the top center of the Bio-Pump", and the outlet port (3/8") is located tangentially on the outer diameter. Notches on the backplate allow the BPX-80 Bio-Pump® to be securely locked onto the pump receptacle of the Bio-Console . The BPX-80 Bio-Pump is designed to be used only with Medtronic Bio-Medicus Bio-Consoles® The BPX-80 Bio-Pump® centrifugal blood pump can be sterilized by either gamma radiation or ethylene oxide (EtO) gas. The Bio-Pump is also available with a heparin bonded (nonleaching) Carmeda® Bioactive Surface.
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    K Number
    K954501
    Device Name
    BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Date Cleared
    1996-01-16

    (110 days)

    Product Code
    DTY
    Regulation Number
    870.4410
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC BIO-MEDICUS, INC.

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