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510(k) Data Aggregation

    K Number
    K212776
    Device Name
    Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
    Manufacturer
    Innovative Health, LLC.
    Date Cleared
    2021-12-20

    (110 days)

    Product Code
    NLG
    Regulation Number
    870.1220
    Why did this record match?
    Product Code :

    NLG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
    Device Description
    The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.
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    K Number
    K211662
    Device Name
    Reprocessed IntellaMap Orion High Resolution Mapping Catheter
    Manufacturer
    Innovative Health, LLC.
    Date Cleared
    2021-11-18

    (170 days)

    Product Code
    NLG
    Regulation Number
    870.1220
    Why did this record match?
    Product Code :

    NLG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
    Device Description
    The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve of an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System.
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    K Number
    K190785
    Device Name
    Reprocessed PentaRay Nav eco High-Density Mapping Catheter
    Manufacturer
    Innovative Health, LLC.
    Date Cleared
    2019-06-25

    (90 days)

    Product Code
    NLG
    Regulation Number
    870.1220
    Why did this record match?
    Product Code :

    NLG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e. recording or stimulation only. The catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The catheter provides location information when used with the compatible Carto 3 EP Navigation Systems. (This catheter is not compatible with Carto 3 EP Navigation Systems prior to Version 3.x.)
    Device Description
    The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the Carto 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 F guiding sheath. This deflectable catheter consists of multiple 3F spines on its distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the Carto 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the Carto 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This device includes an irrigation lumen for connection to a source of continuous anticoagulant fluid. This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.
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