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510(k) Data Aggregation

    K Number
    K012641
    Device Name
    FAS ENDOLUMINAL BRUSH
    Manufacturer
    Date Cleared
    2001-10-15

    (63 days)

    Product Code
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    FAS MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FAS Endoluminal Brush is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.
    Device Description
    The FAS Endoluminal Brush is a single use, sterile disposable medical device. The device itself consists of nylon bristles wound into a stainless steel flexible wire, which is further wound into a stainless steel tubular handle. The brush is enclosed in a plastic sterile sheath that is heat sealed at the proximal end is attached to a Luer lock at its distal end. The Luer lock attachment provides the brush access to catheter lumens in a sterile environment. The FAS Endoluminal Brush kit also contains accessory items including a patient drape, instructions for use, wire clippers, and specimen container and cap, and a patient identification label.
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    K Number
    K993614
    Device Name
    FAS ENDOLUMINAL BRUSH
    Manufacturer
    Date Cleared
    2000-01-18

    (85 days)

    Product Code
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    FAS MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FAS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is suitable for microbiological analysis, from the inner lumen surface of an in-dwelling central venous catheter.
    Device Description
    The FAS Endoluminal Brush is a single use, sterile disposable medical device. The device itself consists of nylon bristles wound into a stainless steel flexible wire, which is further wound into a stainless steel tubular handle. The brush is enclosed in a plastic sterile sheath that is heat sealed at the proximal end and is attached to a Luer lock at its distal end. The Luer lock attachment provides the brush access to the catheter lumen in a sterile environment. The FAS Endoluminal Brush kit also contains accessory items including a measuring tape, patient drape, instructions for use, wire clippers, and specimen container and cap, and a patient identification label.
    Ask a Question

    Ask a specific question about this device

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