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

    CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM

    K Number: DEN050006 · Decision Oct 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    80

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    Basic Information

    Device Name
    CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
    K Number
    DEN050006
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    870.2855
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Cardiomems, Inc.
    Date Received
    August 9, 2005
    Decision Date
    October 28, 2005
    Product Code
    NQH
    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
    NQH Sensor, Pressure, Aneurysm, Implantable

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    Other Clearances by Cardiomems, Inc.

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    K070448 CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
    K061046 CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001