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510(k) Data Aggregation

    K Number
    K000977
    Device Name
    COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
    Manufacturer
    OLSON MEDICAL SALES, INC.
    Date Cleared
    2001-03-23

    (361 days)

    Product Code
    DTR
    Regulation Number
    870.4240
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLSON MEDICAL SALES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993060
    Device Name
    GAS FILTER
    Manufacturer
    OLSON MEDICAL SALES, INC.
    Date Cleared
    2000-03-28

    (197 days)

    Product Code
    JOD
    Regulation Number
    870.4270
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLSON MEDICAL SALES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gas Filter is intended to remove particulate matter from medical gases flowing into the cardiopulmonary bypass circuit for periods up to 6 hours.
    Device Description
    The proposed gas filter and the Gish filter are each made of materials that are commonly used in cardiopulmonary bypass devices and circuits. The Gish filter is made of ABS, and Versapor (Acrylic); the proposed devices are made of hydrophobic laminated glass media, Versapor (Acrylic) and polypropylene.
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    K Number
    K993062
    Device Name
    CHEST DRAINAGE TUBING
    Manufacturer
    OLSON MEDICAL SALES, INC.
    Date Cleared
    1999-12-10

    (88 days)

    Product Code
    DWE
    Regulation Number
    870.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLSON MEDICAL SALES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The chest drainage tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.
    Device Description
    The chest drainage tube is piece of flexible polyvinylchloride tubing that is used as a conduit for body fluids suctioned from the chest cavity and moved into a reservoir following cardiopulmonary bypass procedures. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".
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    K Number
    K992906
    Device Name
    COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
    Manufacturer
    OLSON MEDICAL SALES, INC.
    Date Cleared
    1999-11-10

    (72 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLSON MEDICAL SALES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.
    Device Description
    The adapters are used in connecting oxygenators, reservoirs, filters, tubing, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support. The adapters are of the following generic types: straight adapters with or without luer locking mechanisms (male and female), large bore adapters, three-way connectors, and four-way connectors. The materials used in the manufacturing of these adapters includes polycarbonate, acrylic, and Acrylonitrile-Butadiene-Styrene (ABS). The cleared Medtronics adapters are comprised of plexiglas and Note: polyvinyIchloride.
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