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

    REPLICATION MEDICAL VESSEL GUARD

    K Number: K082782 · Decision Apr 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    192

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    Basic Information

    Device Name
    REPLICATION MEDICAL VESSEL GUARD
    K Number
    K082782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Replication Medical, Inc.
    Date Received
    September 22, 2008
    Decision Date
    April 2, 2009
    Product Code
    OMR
    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
    OMR Vessel Guard Or Cover

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