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

    LUMEND FRONTRUNNER GW CTO CATHETER

    K Number: K031005 · Decision Jun 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    56
    Applicant Total
    11
    Review Days
    79

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    Basic Information

    Device Name
    LUMEND FRONTRUNNER GW CTO CATHETER
    K Number
    K031005
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumend, Inc.
    Date Received
    March 31, 2003
    Decision Date
    June 18, 2003
    Product Code
    PDU
    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
    PDU Catheter For Crossing Total Occlusions

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    Other Clearances by Lumend, Inc.

    K Number Device Name
    K043534 MODIFICATION TO OUTBACK CATHETER
    K040771 MODIFICATION TO OUTBACK CATHETER
    K033535 LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
    K032298 MODIFICATION TO OUTBACK CATHETER
    K023114 LUMEND FRONTRUNNER CTO CATHETER
    K023223 MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER
    K013284 LUMEND FRONTRUNNER CTO CORONARY CATHETER
    K011562 LUMEND PERCUTANEOUS CATHETER
    K014117 MODIFICATION TO OUTBACK CATHETER
    K001577 OUTBACK CATHETER
    Search all 11 clearances from Lumend, Inc. →