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510(k) Data Aggregation

    K Number
    K010099
    Device Name
    ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
    Manufacturer
    Date Cleared
    2001-02-01

    (21 days)

    Product Code
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZCV ,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002603
    Device Name
    ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
    Manufacturer
    Date Cleared
    2001-01-08

    (139 days)

    Product Code
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZCV ,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K003118
    Device Name
    Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
    Manufacturer
    Date Cleared
    2000-12-20

    (76 days)

    Product Code
    Regulation Number
    870.1240
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZCV ,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002481
    Device Name
    ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
    Manufacturer
    Date Cleared
    2000-12-07

    (115 days)

    Product Code
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZCV ,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K991060
    Device Name
    ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
    Manufacturer
    Date Cleared
    2000-04-06

    (373 days)

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

    ZCV ,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Device Description
    The Zynergy Zolution Electrophysiology Catheter is intended as a primary diagnostic tool for intracardiac electrogram recording and pacing, for the determination of conduction times from one location to another, to identify aberrant conduction pathways and to assess arryhthmia vulnerability of the cardiac chambers. Initial sizes to be marketed are 5Fr and 6Fr which include lengths of 1-5mm, electrode spacing of 1mm -1cm and varying in the number of electrodes per catheter of 2 - 20. Various curve styles are available in order to meet anatomical constraints and/or physician preference. The Zynergy Zolution, Zyp-Lok Accessory Cable is a reusable, medical grade cable in lengths of 18", 36" and 72" and 4, 10 & 20 conductor configurations.
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    K Number
    K990689
    Device Name
    ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
    Manufacturer
    Date Cleared
    1999-09-03

    (184 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZCV ,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zynergy Loc-Sure Single Pass Drainage Assembly is a minimally invasive device for percutaneous drainage of cysts, abcesses and fluid collections such as: - Renal cysts . - Renal, hepatic and other abcesses . - Pleural effusions . - Ascitic collections . - Thoracic collections . - Nephrostomies .
    Device Description
    The Zynergy Loc-Sure Single Pass Drainage Set comprised of four components: 1. A radiopaque, semi-coiled, drainage catheter. The distal segment of the catheter has drainage holes on the inside radius to facilitate the draining of fluid from the selected body cavity. 2. The proximal connector cannula flange is comprised of a standard male luer lock. This is inserted into the catheter tubing and is used as an insertion guide for a trocar stylet and may be attached directly to ancillary drainage devices. 3. The trocar stylet is a needle used as a puncture trocar for placing the drainage catheter in the precise location required for the drainage procedure. 4. A suture button is included which may be sutured to the skin for safe extended drainage.
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