BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NOVOSCI READY SYSTEM, MODEL RS-200

    K Number: K033270 · Decision Feb 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    3
    Review Days
    126

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    Basic Information

    Device Name
    NOVOSCI READY SYSTEM, MODEL RS-200
    K Number
    K033270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novosci Corp.
    Date Received
    October 10, 2003
    Decision Date
    February 13, 2004
    Product Code
    KFM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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    Other Clearances by Novosci Corp.

    K Number Device Name
    K063355 D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW
    K033328 NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT