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

    ORIGIN CARDIAC STABLIZER OCCLUDER

    K Number: K970611 · Decision Aug 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    50
    Review Days
    182

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    Basic Information

    Device Name
    ORIGIN CARDIAC STABLIZER OCCLUDER
    K Number
    K970611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Origin Medsystems, Inc.
    Date Received
    February 18, 1997
    Decision Date
    August 19, 1997
    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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