LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K013972
    Device Name
    H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
    Manufacturer
    ACKARD LABORATORIES
    Date Cleared
    2001-12-17

    (14 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACKARD LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The H/S Elliptosphere Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.
    Device Description
    The H/S Elliptosphere Catheter Set can be used for conducting either Hysterosalpingography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and fallopian tubes using ultrasound sonography). All components are provided sterile for single use only.
    Ask a Question

    Page 1 of 1