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The ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

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The VNUS® ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

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The VNUS RFS and RFSFlex devices are intended for use in vessel and tissue coagulation including: Treatment of incompetent (i.e., refluxing) perforator and tributary veins.

The VNUS RFS family of devices is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where blood vessel and tissue coagulation is desired. These devices are compatible with separately cleared Radiofrequency (RF) Generator, and the Instrument Cable manufactured by VNUS Medical Technologies. The VNUS RFS family of devices are sterile disposable devices intended for a singleuse only. The device's function is to deliver bipolar RF energy to the desired treatment site and relay temperature and other feedback to the RF Generator. The disposable device is available in 2 bipolar configurations and multiple lengths for selection by the physician based on preference for method of vessel access, location and length of the vessel to be treated. This submission reflects a name change, minor modification of the indication statement (more specific inclusion of perforator and tributary veins), and minor design changes.

The VNUS Radiofrequency Generator is intended for use with VNUS radiofrequency devices intended for vessel and tissue coagulation.

The VNUS RF Generator, model RFG2 is a bipolar, high frequency electronic, microprocessor and software controlled instrument. It allows the user to set Power, Temperature and Time (Set-points and measured values) as well as measured impedance and user messages. It is provided non-sterile. The model RFG2 is compatible only with the disposable RF delivery devices (e.g., catheters) marketed by VNUS Medical Technologies under separate clearance(s). The instrument cable connects the disposable device to the RF generator. The Instrument Cable is provided non-sterile and is user sterilizable by autoclave. It has been validated to eliminate multiple steam sterilization cycles. If the disposable device has an integrated cable, a separate instrument cable is not necessary.

The VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is intended for use in vessel and tissue coagulation.

The VNUS Vessel and Tissue Coagulation System is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where lood vessel and tissue coagulation is desired. It consist of three main components The VNUS Vessel and Tissue Coagulation Device (proprietary name; TBD), the Radiofrequency (RF) Generator, and the Instrument Cable. The VNUS Vessel and Tissue Coagulation Device is sterile disposable device intended for a single-use only. The device's function is to deliver bipolar RF energy to the intenired treatment site and relay temperature and other feedback to the RF General The disposable device is available in three bipolar configurations for selection by the physician based on preference for method of vessel access. The RF Generator is a high frequency electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time viruals, and provides user displays of Power, Temperature and Time (set-noints and meanured values) as well as measured Impedance and user messages. The RF Generator remains out of the sterile field during use, and is provided non-sterile. The instrument cable connects the disposable device to the RF generator. The Instrument Cable is provided non-sterile, and is user sterilizable by autoclave. It has been validated to multiple steam sterilization cycles. Both ends of the cable are identical to eliminate connection errors.

The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

VNUS® Closure® System

The VNUS® Closure™ System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The VNUS Closure System consists of three main components: The VNUS Closure Catheter, the VNUS RF Generator and the VNUS Instrument Cable. The Closure Catheter is provided sterile, and is a single-use, disposable device. The RF Generator is non-sterile. The Instrument Cable is autoclave sterilized by the user. An optional Footswitch for RF ON/RF OFF is provided for use at the physician's discretion. The RF Generator is a high frequency (460kHz) electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time values, and provides user displays of Power, Temperature and Time (setpoints and measured values) as well as measured Impedance and user messages. Audible tones provide additional feedback to the physician. The RF Generator acts to maintain the set temperature by requlating the power delivered up to the maximum set power. By doing so, the RF Generator controls the temperature at the tip of the catheter. The Closure Catheter is used to provide RF energy to the desired treatment site and relay temperature feedback to the RF Generator. It is designed to deliver the RF energy in a bipolar manner. The Instrument Cable is used to connect the Closure Catheter to the RF Generator.

The VNUS Closure™ System is indicated for use in the coagulation of blood vessels during general surgery.

The VNUS Closure™ System consists of three main components: The VNUS Closure Probe, the VNUS RF Generator and the VNUS Instrument Cable. The Closure Probe is provided Sterile, and is a single-use, disposable device. The RF Generator is non-sterile. The Instrument Cable is autoclave sterilized by the user. An optional Footswitch for RF ON/RF OFF is provided for use at the physician's discretion. The RF Generator is a high frequency electronic, bipolar, software controlled instrument. It allows the user to set Power, Temperature and Time values, and provides user displays of Power. Temperature and Time (setpoints and measured values) as well as measured impedance and other messages. The RF Generator works in a temperature controlled, power limited manner, based on operator settings and temperature feedback provided by a thermocouple in the Closure Probe. The Closure Probe is used to carry RF energy to the desired treatment site and provide temperature feedback to the RF Generator. It is designed to deliver the RF energy in a bipolar manner. The Instrument Cable is used to connect the Closure Probe to the RF Generator.