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

    PROGREAT

    K Number: K033583 · Decision Dec 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    143
    Review Days
    29

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    Basic Information

    Device Name
    PROGREAT
    K Number
    K033583
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Medical Corp.
    Date Received
    November 13, 2003
    Decision Date
    December 12, 2003
    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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    Other Clearances by Terumo Medical Corp.

    K Number Device Name
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    K091329 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
    K082997 TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
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    K082847 PINNACLE ROII INTRODUCER SHEATH
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