BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE

    K Number: K905824 · Decision May 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    26
    Review Days
    136

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    Basic Information

    Device Name
    MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
    K Number
    K905824
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiac Control Systems, Inc.
    Date Received
    December 31, 1990
    Decision Date
    May 16, 1991
    Product Code
    DXY
    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
    DXY Implantable Pacemaker Pulse-Generator

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    Other Clearances by Cardiac Control Systems, Inc.

    K Number Device Name
    K971775 INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
    K946188 CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
    K950210 CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
    K923868 CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
    K904941 MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
    K895110 MAESTRO PACEMAKER TEST MAGNET
    K884023 MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
    K884024 POLYSAFE(TM) IMPLANTABLE PACING LEAD
    K883015 POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
    K883016 POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP
    Search all 26 clearances from Cardiac Control Systems, Inc. →