BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS

    K Number: K905496 · Decision Mar 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    90
    Applicant Total
    53
    Review Days
    94

    Basic Information

    Device Name
    WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS
    K Number
    K905496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Date Received
    December 7, 1990
    Decision Date
    March 11, 1991
    Product Code
    DXZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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