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510(k) Data Aggregation

    K Number
    K152440
    Device Name
    Sydney IVF PVP
    Date Cleared
    2015-09-23

    (27 days)

    Product Code
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILLAM A. COOK AUSTRALIA PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sydney IVF PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
    Device Description
    Sydney IVF PVP is a 10 % polyvinylpyrrolidine solution in a bicarbonate buffered media supplemented with 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. Sydney IVF PVP is ready to use after equilibration to 37℃ and 6% CO2. It is designed to be used by professionals within Assisted Reproduction. This solution is an aseptically filtered sperm medium containing 10% polyvinylpyrrolidone. The PVP increases the viscosity of the solution to facilitate the capture of motile sperm for intracytoplasmic sperm injection (ICSI) procedures during Assisted Reproduction Techniques (ART) procedures. Sydney IVF PVP is provided in glass vials with FluroTec coated rubber stoppers held in place with a tamper evident seal. It is available in a 5 pack carton box with each vial containing 200 µL Sydney IVF PVP.
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