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The PowerWire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater, including vessels with stents.

PowerWire Radiofrequency Guidewire is a sterile, single-use device used to deliver radiofrequency (RF) energy. It is shipped as a sterile device kit containing one (1) PowerWire RF Guidewire and one (1) RFP-100A Connector Cable (separately cleared under K230571) sealed in a double compartment pouch, which is then placed inside a shelf box and then an outer cardboard box. The device is sterilized using ethylene oxide. The device consists of a core wire surrounded by a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable (K230571) and has an active tip at the distal end to deliver radiofrequency energy. The PowerWire Radiofrequency Guidewire must be used with an approved Baylis Radiofrequency Puncture Generator (Baylis RF Generator K122278) and RFP-100A Connector Cable (K230571). The connector cable connects the RFP-100A BMC Radiofrequency Puncture Generator (RFP-100A Generator) to the PowerWire RF Guidewire to enable radiofrequency (RF) power to be delivered from the Generator to a PowerWire RF Guidewire. The PowerWire Radiofrequency Guidewire delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrode. All models of the PowerWire Radiofrequency Guidewire have a usable length of 250cm and an outside diameter of 0.035". The various straight and curved distal configurations of the wires provide physicians with flexibility of choosing the most suitable guidewire for accessing target tissue in tortuous pathways in the body, with either straight or angled distal tips. Once the occlusion is crossed, the PowerWire Radiofrequency Guidewire can act as a rail for balloon or stent catheters, or can be exchanged for other guidewires or devices cleared for peripheral interventional procedures. The PowerWire Radiofrequency Guidewire is designed to be compatible with most balloon and stent catheters approved for use in peripheral interventional procedures.

The intended use of the RFP-100A Connector Cable (Single Use) is to connect the RFP-100A Generator to separately cleared compatible RF devices.

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