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

    SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER

    K Number: K896203 · Decision Feb 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    35
    Applicant Total
    10
    Review Days
    98

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    Basic Information

    Device Name
    SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
    K Number
    K896203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Solco Basle, Inc.
    Date Received
    October 26, 1989
    Decision Date
    February 1, 1990
    Product Code
    CAK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAK Microfilter, Blood Transfusion

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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
    K896858 SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM
    K883058 SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM
    K872590 SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM
    K872157 HALL VEIN STRIPPER
    K843821 SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS