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

    VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520

    K Number: K022823 · Decision Jul 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    6
    Review Days
    675

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    Basic Information

    Device Name
    VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
    K Number
    K022823
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4885
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Geister Medizin Technik GmbH
    Date Received
    August 26, 2002
    Decision Date
    July 1, 2004
    Product Code
    MGZ
    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
    MGZ Valvulotome

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