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

    EN SNARE ENDOVASCULAR SNARE SYSTEM

    K Number: K092343 · Decision Aug 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    31
    Applicant Total
    178
    Review Days
    3

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    Basic Information

    Device Name
    EN SNARE ENDOVASCULAR SNARE SYSTEM
    K Number
    K092343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    August 4, 2009
    Decision Date
    August 7, 2009
    Product Code
    MMX
    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
    MMX Device, Percutaneous Retrieval

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