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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    K2 MEDICAL VASCULAR CLAMPS

    K Number: K120492 · Decision Apr 30, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    K2 MEDICAL VASCULAR CLAMPS
    K Number
    K120492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    K2 Medical GmbH & Co. KG
    Date Received
    February 17, 2012
    Decision Date
    April 30, 2012
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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    Other Clearances by K2 Medical GmbH & Co. KG

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