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510(k) Data Aggregation

    K Number
    K012220
    Device Name
    TAO EMBRYO TRANSFER CATHETER SYSTEM
    Date Cleared
    2001-08-27

    (42 days)

    Product Code
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    TTJ BIOMEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended Use: Single use, limited exposure (<24 hours), mucosal membrane surface contact, embryo transfer procedures. The Tao embryo transfer catheter system is intended for use for the introduction of embryos into the uterine cavity. The procedure should be completed by an individual with requisite experience and education in the process of IVF and embryo transfers, and the procedure should be completed in a facility suited for IVF and embryo transfers. The catheter system consists of a single use, ETO sterilized inner catheter and outer sleeve.
    Device Description
    The Tao Embryo Transfer Catheter system consists of two devices which are used for introducing embryos into the uterine cavity. This sterile, single use embryo transfer system consists of a pellethane outer sleeve and a polyethelene inner catheter. The outer sleeve has a distal portion which has an easy-to-shape design. At the tip, the outer sleeve is protected by a sphere-shaped soft cap. The revolutionary design of the cap not only significantly minimizes trauma when passing the cervix, but it also minimizes possible mucus, blood and bacterial contamination of the inner catheter and embryos. The inner catheter has two different designs, with one having an end-port and the other a side-port.
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