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The Hansen Medical Magellan™ Robotic Catheter 9Fr is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic Catheter 9Fr Long Length (80 cm) is also indicated for use as a conduit for manual placement of therapeutic devices in the neuro vasculature. The Magellan™ Robotic Catheter 9Fr is intended to be used with the Hansen Medical Magellan™ M Robotic System and accessories.

The proposed change to the Hansen Medical Magellan™ Robotic Catheter (MRC) 9Fr is to the Indications for Use only; there is no change to the fit, form, or function of the device or to any of its components and accessories cleared under K132369. The MRC 9Fr is a telescoping design comprised of a steerable Leader within a steerable Guide and is designed to be used with the Hansen Medical Magellan™ Robotic System (Magellan System). The distal sections of each Hansen Catheter component articulate individually and the distal end of the Leader can extend up to 21cm beyond the distal end of the Guide. The Leader is a tubular catheter with four pull wires articulating the distal 3cm. The Leader has a 6Fr outer diameter and 3Fr inner diameter, and is available in 125cm, 141cm, and 158cm lengths. The Leader fits inside the Guide and is only used in conjunction with the Guide. The distal end of the Leader has a 3cm flexible articulating section. The Leader has a radiopaque marker band between the articulating section and the atraumatic tip. The tip extends 4mm distal to the marker band. The Guide is a tubular catheter with four pull wires articulating the distal 2.8cm. The Guide has a 6Fr inner diameter and 9Fr outer diameter. The Guide is available in 50cm, 65cm, or 80cm lengths. The Guide fits around the Leader and may be used with or without the Leader. When the Leader is removed from the Guide, a 6Fr compatible percutaneous catheter may be delivered through the Guide. The Hansen Catheter family consists of three different lengths of Leader and Guide pairs, and all sizes are sterilized via EtO for single use only. However, the MRC 9Fr Short (50cm) and MRC 9Fr Medium (65cm) catheters are not included for the expanded indication as they are not long enough to access the target anatomy.

The Hansen Medical Magellan™ Robotic Catheter eKit is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan™ Robotic Catheter eKit is intended to be used with the Hansen Medical Magellan™ Robotic System and accessories.

The Hansen Medical Magellan™ Robotic Catheter eKit (MRC eKit) incorporates Microcatheter Driver components to be used in conjunction with the Magellan Robotic Catheter 6Fr (MRC 6Fr ) cleared under K515463. Both the predicate device (MRC 6Fr) and the MRC eKit are comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a non-articulating Leader. The devices are both provided in two lengths (60cm and 95cm) and have been designed to be used with Hansen Medical Magellan Robotic System. Both the MRC 6Fr and the MRC eKit are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The MRC eKit is comprised of the Hansen Medical 6Fr Guide catheter that is found in the commercialized product MRC 6Fr, and Microcatheter Driver components. The Microcatheter Driver components include a Microcatheter Support, a Microcatheter Driver base, a Connector Tube, a Support Tube packaged with and for use with the Leader, and a Microcatheter Valve. These components function the same as the Wire Support in the MRC 6Fr device to robotically insert and retract the Leader. Modifications have been made to now allow for robotic insertion and retraction of third-party inner catheters / microcatheters compatible with 5F Guiding catheters (< 0.056" OD). There are no new materials or colorants used in the design of the Microcatheter Driver components. The main body of the catheter and the splayer remain unchanged. The optional proprietary non-articulating MRC 6Fr Leader (4.2 Fr OD x 3 Fr ID) is also available for use with the MRC eKit. The MRC 6Fr & eKit Leader is the same MRC 6Fr Leader cleared under K515463; only now it will be packaged with a Support Tube for use with the microcatheter driver. Identical to the MRC 6Fr, the MRC eKit is provided sterile and is intended for single use only. The eKit is one of several compatible devices available for use with Hansen Medical's Magellan Robotic System (cleared under K111004, K132369, K141614, and K151730).

The Hansen Medical Magellan Robotic Catheter 6Fr is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic Catheter 6Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

The Magellan Robotic Catheter 6Fr v1.2 and accessories are a modification of the predicate Magellan Robotic Catheter 6Fr (MRC 6Fr) and accessories cleared under K133552. Both the predicate device and the modified Magellan Robotic Catheter 6Fr are comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a nonarticulating Leader (Inner Catheter). The devices are provided in two lengths (60cm and 95cm). Like the predicate device, the MRC 6Fr v1.2 is designed to be used with Hansen Medical Magellan Robotic System and is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. Both the MRC 6Fr v1.2 and the predicate may also be used for delivery of diagnostic contrast agents. The modified MRC 6Fr is compatible with power contrast injection systems up to a maximum of 600 psi. Whereas, the predicate device is rated for a maximum pressure of 100 psi. The device is provided sterile and is intended for single use only. The catheter is one of several compatible devices available for use with Hansen Medical's Magellan Robotic System cleared under K111004, K132369 and K141614.

The Hansen Medical Magellan Robotic System and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

The Hansen Medical Magellan Robotic System and Accessory Components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the vasculature, while enabling a physician to remain seated and away from the x-ray radiation source. The modification to the Magellan Robotic System is software update referred to as Magellan v1.9.1.

The Hansen Medical Magellan Robotic System and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

The Hansen Medical Magellan Robotic System and accessory components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the vasculature, while enabling a physician to remain seated and away from the x-ray radiation source. The modification adds a mechanical joint between the Magellan Robotic System Rail and Adapter Plate to facilitate removal. The Magellan Robotic System and accessory components are compatible with Hansen Medical robotically steerable catheters approved under previous 510(k)s.

The Hansen Medical Magellan Robotic Catheter 6Fr is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic Catheter 6Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

The Magellan Robotic Catheter 6Fr (MRC 6Fr) and accessories are a modification of the predicate Magellan Robotic Catheter 9Fr (MRC 9Fr) and accessories cleared under K132369. The Magellan Robotic Catheter 6Fr is a smaller size catheter comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a non-articulating Leader (Inner Catheter). The device is provided in two lengths (60cm and 95cm). Like the predicate device, the MRC 6Fr is designed to be used with Hansen Medical Magellan Robotic System and is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The MRC 6Fr may also be used for delivery of diagnostic contrast agents. The device is provided sterile and is intended for single use only. The catheter is designed to expand Hansen Medical's market offering of compatible devices available for use with the Magellan Robotic System cleared under K132369.

Magellan Robotic System: The Hansen Medical Magellan Robotic System and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters. Magellan Robotic Catheter 9Fr. The Hansen Medical Magellan Robotic Catheter 9Fr is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic Catheter 9Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

The Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr and Accessory Components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the vasculature, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Magellan System were made to expand system-quide wire compatibility, provide alternate quide wire navigation using the Master Input Device in addition to the existing Workstation and Bedside Controllers and to provide support for future compatible Hansen vascular catheters.

The Hansen Medical Artisan Extend Control Catheter is intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx ™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical. The Artisan Extend Control Catheter is intended to be used with the Hansen Medical Sensei® X Robotic Catheter System.

The Hansen Medical Artisan Extend Control Catheter is designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The Artisan Extend Control Catheter consists of a Steerable Guide Catheter (SGC) and Sheath. The Control Catheter is designed to be used with the Hansen Medical Sensei® X Robotic Catheter System.

The Hansen Medical Vascular Catheter Control System, Hansen Catheter and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Hansen Medical Magellan Robotic System and NorthStar Robotic Catheter and Accessory Components are designed to facilitate remote navigation to anatomical targets in the peripheral vasculature. Subsequent to navigation, the system provides a conduit for manual placement of therapeutic devices. The Magellan Robotic System's operating principles are similar to those of the Sensei X Robotic Catheter System. The fundamental concept of the robotic system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the vasculature, while enabling a physician to remain seated and away from the x-ray radiation source.