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510(k) Data Aggregation

    K Number
    K201237
    Device Name
    Velano Vascular Blood Collection Adapter 
    Manufacturer
    Date Cleared
    2022-10-03

    (879 days)

    Product Code
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Velano Vascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Velano Vascular Blood Collection Adapter is indicated for use as a blood collection system that manually diverts the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
    Device Description
    The Blood Collection Adapter is a sterile, single-use device that removes the initial portion of the blood specimen (potentially contaminated) into a waste or discard tube prior to collecting a subsequent blood sample. The Blood Collection Adapter is comprised of a transfer device, a waste tube, a skirt that holds the waste tube in place, and an adapter inside the transfer device that is used for narrow neck culture tubes and additional blood collection tubes. The device is designed to be attached to a newly placed IV-line, vascular access device, or venipuncture needle set and is not intended for blood specimen collection from preexisting lines or IV site. Place a new peripheral IV catheter prior to drawing blood sample. The device collects approximately 3mL of the initial blood sample into the waste tube. The subsequent blood sample is collected directly into a culture bottle (not provided by Velano Vascular) or into an evacuated tube for additional processing.
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