LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040625
    Device Name
    ATAD ARD CATHETER
    Manufacturer
    ATAD DEVELOPMENTS LTD.
    Date Cleared
    2005-01-18

    (315 days)

    Product Code
    HDY
    Regulation Number
    884.4260
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATAD DEVELOPMENTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atad Pre-Induction Cervical Dilator is indicated for mechanical dilation of the cervical canal prior to labor induction a term when the cervix is unfavorable for induction.
    Device Description
    The Atad Dilator is an 18Fr, 400mm, natural latex, three-lumen, double latex balloon catheter with a corresponding valve for each balloon and a disabled third lumen that is not intended to be used.
    Ask a Question

    Page 1 of 1