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

    CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE

    K Number: K884481 · Decision Jan 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    7
    Review Days
    80

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    Basic Information

    Device Name
    CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE
    K Number
    K884481
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mallinckroot, Inc.
    Date Received
    October 22, 1988
    Decision Date
    January 10, 1989
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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