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510(k) Data Aggregation

    K Number
    K972572
    Device Name
    SINGLE LUMEN EMBOLECTOMY CATHETER
    Date Cleared
    1998-01-13

    (187 days)

    Product Code
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN BIOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Removing arterial emboli.
    Device Description
    Single Lumen Embolectomy catheter with three 100% silicone balloons. Catheter intended for use in removing arterial emboli. Sizes 2 to 7 French.
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