LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040187
    Device Name
    MEDICINAL LEECHES
    Manufacturer
    RICARIMPEX SAS
    Date Cleared
    2004-06-21

    (145 days)

    Product Code
    NRN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    RICARIMPEX SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An adjunct to the healing of graft tissue when problems of venous congestion may delay healing, or to when problems of venous congestion by creating prolonged localized bleeding.
    Device Description
    Medicinal Leeches, a blood sucking aquatic animal living in fresh water and subject to regulation by the U.S. Fish and Wildlife Service, are a preamendment, unclassified device which, by nature of their historical use and documented value in various post surgical situations.
    Ask a Question

    Page 1 of 1