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

    URSA ANGIOGRAPHIC CATHETER

    K Number: K123818 · Decision Mar 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    497
    Applicant Total
    2
    Review Days
    82

    Basic Information

    Device Name
    URSA ANGIOGRAPHIC CATHETER
    K Number
    K123818
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CURATIVE MEDICAL TECHNOLOGY, INC.
    Date Received
    December 12, 2012
    Decision Date
    March 4, 2013
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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