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    K Number
    K011847
    Device Name
    ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
    Manufacturer
    ZYNERGY CARDIO VASULAR (ZCV), INC.
    Date Cleared
    2001-07-13

    (30 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZYNERGY CARDIO VASULAR (ZCV), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is indicated for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording.
    Device Description
    Same as the predicate Zynergy Zolution Electrophysiology catheter, the Zynergy Z.5000 Electrophysiology catheter is comprised of a radiopaque tubing reinforced with stainless steel braiding. The soft tip is fitted with electrodes in varying sizes and configurations. The back end of the catheter is comprised of an electrical connector.
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