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

    CareLink SmartSync Device Manager - Pacing System Analyzer

    K Number: K163008 · Decision Feb 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    57
    Review Days
    123

    Basic Information

    Device Name
    CareLink SmartSync Device Manager - Pacing System Analyzer
    K Number
    K163008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3720
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Inc.
    Date Received
    October 28, 2016
    Decision Date
    February 28, 2017
    Product Code
    DTA
    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
    DTA Tester, Pacemaker Electrode Function

    Similar 510(k) Clearances

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

    MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADAPTER CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL EP-2 CLINICAL STIMULATOR

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

    Other Clearances by Medtronic, Inc.

    K Number Device Name
    K250558 SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
    K243892 Affera Integrated Mapping System
    K243435 Magnetic Localization Patch Kit (AFR-00021)
    K241828 Affera Integrated Mapping System; Impedance Localization Patch Kit
    K241259 Amplatz Goose Neck Snare Kit
    K240693 LINQ II™ Insertable Cardiac Monitor (ICM)
    K233943 Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
    K231206 DLP Silicone Coronary Artery Ostial Cannulae
    K233562 LINQ II Insertable Cardiac Monitor
    K233397 Cosine-10TM Diagnostic Catheter
    Search all 57 clearances from Medtronic, Inc. →