This product is an over-the-wire (OTW) balloon dilatation catheter with a platinum-iridium alloy radiopaque marker, coated from the distal tip of the catheter to the proximal end of the balloon. It consists of a balloon, cushion tip, inner tip, shrink tube, strain relief, Y-connector branch, and catheter shaft. The manufacturing materials are: Balloon: Pebax7033 and Vestamid L2101F; Cushion tip: Pebax7033; Inner tip: Grilamid L20; Shrink tube: Pebax6333; Strain relief: Ethylene-Vinyl Acetate Copolymer; Y-connector branch: Pebax7033; Catheter shaft: Pebax7033 containing BaSO₄; Coating: Silicone oil and Silicone Lubricant 360. The product is sterilized with ethylene oxide and intended for single use.