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

    SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM

    K Number: K896858 · Decision Apr 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    10
    Review Days
    121

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    Basic Information

    Device Name
    SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM
    K Number
    K896858
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Solco Basle, Inc.
    Date Received
    December 5, 1989
    Decision Date
    April 5, 1990
    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 Solco Basle, Inc.

    K Number Device Name
    K913247 SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
    K913177 SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
    K915867 SOLCOVAC WOUND DRAINAGE SYSTEM
    K896857 SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
    K896203 SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
    K883058 SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM
    K872590 SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM
    K872157 HALL VEIN STRIPPER
    K843821 SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS