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

    SMI CARDIOVASCULAR PATCH

    K Number: K122105 · Decision Dec 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    1
    Review Days
    143

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    Basic Information

    Device Name
    SMI CARDIOVASCULAR PATCH
    K Number
    K122105
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solinas Medical, Inc.
    Date Received
    July 17, 2012
    Decision Date
    December 7, 2012
    Product Code
    DXZ
    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
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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