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

    HAEMONETICS 40U RBC FILTER BAG

    K Number: K061103 · Decision May 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    35
    Applicant Total
    28
    Review Days
    27

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    Basic Information

    Device Name
    HAEMONETICS 40U RBC FILTER BAG
    K Number
    K061103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Haemonetics Corp.
    Date Received
    April 20, 2006
    Decision Date
    May 17, 2006
    Product Code
    CAK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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 Haemonetics Corp.

    K Number Device Name
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    K062801 SMARTSUCTION SOLO DEVICE
    K053000 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
    K052626 SMARTSUCTION HARMONY DEVICE
    K043127 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
    K014083 HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
    K993581 HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
    K953681 HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
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