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

    SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)

    K Number: K133481 · Decision May 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    23
    Review Days
    196

    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 (ICM)
    K Number
    K133481
    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, Inc.
    Date Received
    November 13, 2013
    Decision Date
    May 28, 2014
    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, Inc.

    K Number Device Name
    K172393 Advisor HD Grid Mapping Catheter, Sensor Enabled
    K163407 Confirm Rx Insertable Cardiac Monitor (ICM) System
    K161171 PressureWire X Guidewire
    K161102 Nanostim Introducer Kit
    K160716 The Nanostim Introducer Kit
    K140793 NANOSTIM INTRODUCER KIT
    K131592 ENLIGHTN RENAL GUIDE CATHETER
    K073700 6F PROXIS SYSTEM
    K042734 SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
    K022363 SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
    Search all 23 clearances from St. Jude Medical, Inc. →