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The Sphere-9Dx Diagnostic Catheter is indicated for electrophysiological mapping (recording and stimulation) of cardiac structures in the heart. This catheter is intended to obtain electrograms in the atrial regions of the heart. The catheter provides location information when used with a compatible Affera Mapping System.

The Sphere-9Dx Diagnostic catheter (AFR-00009) is a steerable irrigated multi-electrode catheter with a bidirectional deflecting tip intended for intracardiac mapping (stimulation and recording). The catheter includes an expandable lattice electrode array that fits a 2.7 mm (8 Fr) straight introducer sheath or a 2.8 mm (8.5 Fr) curved or deflectable sheath and expands to a 9.3 mm diameter in the cardiac chamber. The catheter is supplied with an insertion tool that must be used to aid in collapsing the expandable lattice electrode array for insertion into an introducer or guiding sheath. The expandable lattice electrode array contains 9 mini surface electrodes mounted on its surface with roughly 5 mm spacing to collect local electrograms and monitor local impedance. All mini surface electrodes may be used for recording or stimulation.

The Advisor™ HD Grid X 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.

The AdvisorTM HD Grid X Mapping Catheter, Sensor EnabledTM, is a sterile, single use, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two paddle magnetic sensors, two distal shaft ring electrodes, two shaft magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an insertion tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is intended to be used with the EnSiteTM X EP System and other accessories, including the connecting cable and commercially available irrigation pumps.

PENTARAY® NAV ECO High Density Mapping Catheter: The PENTARAY® NAV ECO High Density Mapping Catheter is indicated for multiple 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. The PENTARAY® NAV ECO High Density Mapping Catheter provides location information when used with compatible CARTO®3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to version 3.x). DECANAV® Mapping Catheter: The DECANAV® Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the coronary sinus. In addition, the catheter is used with compatible CARTO® 3 System to provide catheter tip location information. Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology and Auto ID: The Webster® CS Catheter is indicated for electrophysiological mapping of cardiac structures i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

PENTARAY® NAV eco High Density Mapping Catheter: The PENTARAY® NAV eco High Density Mapping Catheter is a multi-electrode diagnostic catheter designed to facilitate electrophysiological mapping of all structures in the heart (recording and stimulation). The catheter's distal end is a flower-shaped probe with 5 spines that radiate from the center. Each spine has 4 ring electrodes that are used for stimulation and recording within the heart. The flower is available in a 30mm diameter and several ring spacing configurations to achieve optimal mapping and contact with various cardiac structures. DECANAV® Mapping Catheter: The DECANAV® Catheter has been designed to be used with the CARTO® 3 Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The DECANAV® Catheter has a single proximal electrode that can be used for unipolar recording signals. The DECANAV® Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in various curve types. The plane of the curved tip can be rotated during use. The DECANAV® Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors. Webster® CS Catheter with Auto ID: The Webster® Coronary Sinus Catheter is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 6 FR catheter with a usable length of 115 cm. The catheter has a high-torque shaft with a deflectable tip selection containing an array of platinum electrodes that can be used for stimulation and recording. Standard features of this catheter include a braided 6 FR deflectable tip section with an array of platinum electrodes that includes a 2 mm tip dome. The braided tip is controlled by a proximal hand piece that features a thumb operated sliding piston, and is offered in a various curve types. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate position of the catheter tip at the desired site. The catheter is equipped with Electronically Erasable Programmable Read Only Memory (EEPROM) which is used to store unique catheter identification information. CARTO® EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information. The catheter interfaces with CARTO® EP Navigation Systems equipped with Auto ID Technology via interface cables with the appropriate connectors. Webster® CS Catheter with EZ Steer Technology: The Webster® CS Catheters with EZ Steer Bi-directional Technology (D-1263-04-S and D-1263-05-S) are diagnostic. 7F, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-04-S) and DF (D-1263-05-S). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The following cables are used to provide a means for interface of the catheters with the appropriate equipment: - D-1221-21 - D-1221-26 - D-1221-25 Webster® CS Catheter with EZ Steer Technology and Auto ID: The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-06-S and D-1263-07-S) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bidirectional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-06-S) and DF (D-1263-07-S). These catheters include a handle with a Rocker Lever which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The Webster CS Catheters with EZ Steer Bi-directional Technology and Auto ID (D-1263-06-S & D-1263-07-S) are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information. CARTO 3 EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information. The catheters interface with CARTO 3 EP Navigation Systems via an interface cable (D-1286-16) with the appropriate connectors.

For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli.

The Ablacath™ Mapping Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. They may also be used to deliver externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system. The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into an 8.5 F sheath. The Ablacath Mapping Catheters are available in two (2) model numbers representing two (2) basket sizes.

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or simulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The cather provides location information only when used with a compatible version of the CARTO™ 3 System.

The OPTRELL™ Mapping Catheter with TRUEref™ Technology has been designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. The OPTRELL™ Mapping Catheter with TRUEref™ Technology is deployed in the heart through an 8.5 F guiding sheath. This bi-directional deflectable catheter includes six (6) parallel 2 Fr spines that are joined to form three (3) loops on the deflectable tip. Each spine has six (6) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 6 (6x6) grid. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO™ 3 EP Navigation System. Below the spines on the deflectable tip are three (3) electrodes that allow visualization of the tip on the CARTO™ 3 System. The TRUEref™ Electrode, which is embedded in the distal end of the irrigation lumen, can be used as an internal close unipolar reference electrode within the heart chamber. Rotating the catheter's Rocker Lever clockwise or counterclockwise deflects the tip; rotating the Rocker Lever to the neutral position straightens the tip. The catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid. Lastly, the proposed catheter is offered in the same deflectable curve offerings as the predicate.

The AcQMap® 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart. The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge Density/Voltage heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations of interest within the heart. Refer to for images of the device. The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability. The shaft of the catheter has a shaft marker band, as an optional feature, to allow the user to visualize whether the distal array is inside or outside the AcQGuide MAX Steerable Sheath (900200).

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple 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. The cather provides location information only when used with a compatible version of the CARTO™ 3 System.

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. It is designed for deployment in a heart chamber through an 8.5 Fr guiding sheath. This bi-directional deflectable catheter includes six (6) parallel 2 Fr spines that are joined to form three (3) loops on the deflectable tip. Each spine has eight (8) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 8 (6x8) grid. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO™ 3 EP Navigation System. Below the spines on the deflectable tip are three (3) electrodes that allow visualization of the tip on the CARTO™ 3 System. The TRUEref™ Electrode, which is embedded in the distal end of the irrigation lumen, can be used as an internal close unipolar reference electrode within the heart chamber. Rotating the catheter's Rocker Lever clockwise or counterclockwise deflects the tip; rotating the Rocker Lever to the neutral position straightens the tip. The catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.

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. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x.

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 Fr guiding sheath. This deflectable catheter consists of multiple 3 Fr spines on the 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 catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.

The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart. The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector, as shown in Figure II.I. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations and directions of interest within the heart. Refer to Figure 10.1 for images of the device. The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability.

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.

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.