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

    THE PILOT SCIMED TORQUE DEVICE

    K Number: K896108 · Decision Jan 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    85
    Applicant Total
    109
    Review Days
    78

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    Basic Information

    Device Name
    THE PILOT SCIMED TORQUE DEVICE
    K Number
    K896108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Scimed Life Systems, Inc.
    Date Received
    October 23, 1989
    Decision Date
    January 9, 1990
    Product Code
    LOX
    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
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

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