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

    ILT 0.014 CATHETER, MODEL C114NL2

    K Number: K001992 · Decision Sep 25, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    20
    Review Days
    88

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    Basic Information

    Device Name
    ILT 0.014 CATHETER, MODEL C114NL2
    K Number
    K001992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intra Luminal Therapeutics, Inc.
    Date Received
    June 29, 2000
    Decision Date
    September 25, 2000
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Intra Luminal Therapeutics, Inc.

    K Number Device Name
    K050916 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
    K050915 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
    K041973 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
    K040481 SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
    K040037 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
    K033929 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
    K032031 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
    K033708 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
    K031842 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
    K032784 ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
    Search all 20 clearances from Intra Luminal Therapeutics, Inc. →