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

    SJM CONFIRM IMPLANTABLE CARDIAC MONITOR

    K Number: K122090 · Decision Nov 15, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    122

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
    K Number
    K122090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    St. Jude Medical, Cardiac Rhythm Management Divisi
    Date Received
    July 16, 2012
    Decision Date
    November 15, 2012
    Product Code
    MXC
    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
    MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MXC), ordered by most recent decision date.

    Assert-IQ™ Insertable Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Jot Dx Insertable Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Confirm Rx Insertable Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Confirm Rx Insertable Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Confirm Rx Insertable Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by St. Jude Medical, Cardiac Rhythm Management Divisi

    K Number Device Name
    K120296 CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
    K120298 CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
    K111943 AGILLS PF DELIVERY SYSTEM
    K103250 CPS DIRECT SL II SLITTABLE OUTER CATHETER
    K093858 PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
    K092075 CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
    K090613 CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2
    K080924 MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
    K072864 ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM