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

    TRUE BA V BALLOON VALVULOPLASTY CATHETER

    K Number: K141985 · Decision Sep 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    21
    Applicant Total
    645
    Review Days
    58

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    Basic Information

    Device Name
    TRUE BA V BALLOON VALVULOPLASTY CATHETER
    K Number
    K141985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1255
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    July 22, 2014
    Decision Date
    September 18, 2014
    Product Code
    OZT
    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
    OZT Balloon Aortic Valvuloplasty

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