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

    MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000

    K Number: K012926 · Decision Sep 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    33
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
    K Number
    K012926
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Endocardial Solutions, Inc.
    Date Received
    August 31, 2001
    Decision Date
    September 28, 2001
    Product Code
    MTD
    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
    MTD Catheter, Intracardiac Mapping, High-Density Array

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    Other Clearances by Endocardial Solutions, Inc.

    K Number Device Name
    K042493 ENSITE SYSTEM, MODEL EE3000
    K033211 ENSITE SYSTEM
    K030129 MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
    K001437 ENSITE 3000 SYSTEM, MODEL EE3000
    K993376 ENSTYLET MODELS EC0010, EC0020
    K992479 ENSITE 3000 SYSTEM
    K983456 ENSITE 3000 SYSTEM