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

    SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM

    K Number: K963014 · Decision Nov 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    7
    Review Days
    108

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    Basic Information

    Device Name
    SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
    K Number
    K963014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nitinol Medical Technologies, Inc.
    Date Received
    August 2, 1996
    Decision Date
    November 18, 1996
    Product Code
    DTK
    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
    DTK Filter, Intravascular, Cardiovascular

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    Other Clearances by Nitinol Medical Technologies, Inc.

    K Number Device Name
    K970099 SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
    K963016 SIMON NITINOL FILTER SYSTEM
    K944353 SIMON NITINOL FILTER
    K940489 SIMON NITINOL FILTER
    K912144 SIMON NITINOL FILTER, MODIFICATION
    K894703 SIMON NITINOL FILTER