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The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries.

The Silk Road Medical ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is a standard rapid exchange (RX) 0.014" Percutaneous Transluminal Angioplasty (PTA) catheter with a proximal single lumen and distal coaxial lumen tubing with a dilatation balloon, and an atraumatic, tapered tip. The proximal luer lock hub allows for connection with a balloon inflation device for inflation with diluted contrast medium. The second lumen in the distal shaft permits the use of an 0.014" guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon has two radiopaque marker bands to aid in positioning the balloon in the stenosis, located either 25 or 35 mm apart as indicated on the package label. An external position marker is located 32.5 cm from the distal tip to indicate the relative position of the catheter tip to the guiding catheter/introducer sheath. The total working length of the catheter is 75 cm. The Silk Road Medical ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter will complement the TCAR procedure.

The provided text describes a medical device called the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter and its substantial equivalence submission to the FDA. The document outlines acceptance criteria and the studies conducted to prove the device meets these criteria.

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document details various tests performed and states that the device "met all established requirements" and "all tests passed successfully." While specific quantitative acceptance criteria or exact performance values are not explicitly listed in a comparative table within the provided text, the document indicates that the device met the pre-determined acceptance criteria for each test.

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