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

    MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH

    K Number: K034061 · Decision Jan 30, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    268
    Registration Numbers
    268
    Same Product Code
    682
    Applicant Total
    430
    Review Days
    30

    Basic Information

    Device Name
    MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
    K Number
    K034061
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BOSTON SCIENTIFIC CORP.
    Date Received
    December 31, 2003
    Decision Date
    January 30, 2004
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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