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

    C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM

    K Number: K960006 · Decision Jul 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    2
    Review Days
    211

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    Basic Information

    Device Name
    C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
    K Number
    K960006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius AG
    Date Received
    January 2, 1996
    Decision Date
    July 31, 1996
    Product Code
    CAC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAC Apparatus, Autotransfusion

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    Other Clearances by Fresenius AG

    K Number Device Name
    K971274 C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET