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

    CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001

    K Number: K070448 · Decision Mar 15, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
    K Number
    K070448
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2855
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiomems, Inc.
    Date Received
    February 15, 2007
    Decision Date
    March 15, 2007
    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.

    K Number Device Name
    K082191 CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
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    DEN050006 CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM