Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162064
    Device Name
    CrossBay IVF Embryo Transfer Catheter Set
    Manufacturer
    CrossBay Medical Inc.
    Date Cleared
    2017-01-05

    (163 days)

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

    CrossBay Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.
    Device Description
    The CrossBay IVF Embryo Transfer Catheter Set is a sterile, single use device composed of disposable components supporting the transfer of an in vitro fertilized embryo to the uterus. The CrossBay IVF Embryo Transfer Catheter Set is comprised of a Delivery Catheter with a 6 Fr Inner Catheter and everting membrane that accesses the cervix and uterine cavity; a 3cc syringe for supplying aseptically filtered media or saline to the Delivery Catheter; and a 3 Fr Embryo Transfer Catheter that is supplied in a separately sealed pouch. The Delivery Catheter contains an acorn tip for seating the distal end of the Delivery Catheter at the exocervix. The Embryo Transfer Catheter contains a stainless steel band at the distal end to provide additional echogenicity to the catheter for ultrasound guided procedures. The Embryo Transfer Catheter has markings on its proximal end at 1 cm intervals to aid in determining the depth of insertion. The Embryo Transfer Catheter can extend a maximum distance of 4 cm beyond the distal end of the fully everted membrane when completely inserted into the Delivery Catheter. The maximum insertion depth of the Embryo Transfer Catheter and fully everted membrane is 9 cm.
    Ask a Question

    Page 1 of 1