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  • Devices designed for use in the introduction of catheters into the body cavities, ducts, or vessels. These introducers may consist of simple devices (e.g., devices that include an introducer needle with a cannula, guiding catheters, sheaths) or complete assemblies. Those complete assemblies may include dedicated devices and/or some or all of the following components: a needle, stylet or trocar, a dilator, a guidewire, and a sheath. Dedicated catheter introducers are available for a variety of catheters and procedures, such as catheter insertion into the vasculature (e.g., peripheral veins, central venous), the urinary and biliary tracts, and also for drainage (e.g., pleural catheter introducers). Procedure kits and/or trays including all necessary devices and supplies needed for catheterization are also available.
  • Needles designed for the initial percutaneous insertion of a catheter. These needles typically consist of a hollow, blunt, tapered cannula with a sharp obturator inside. Catheter-insertion needles may be used to introduce drainage catheters in wounds, for initial introduction of spinal catheters, for initial introduction of peritoneal catheters for dialysis and/or drug infusion, and, more frequently, for the insertion of percutaneous venous and/or arterial catheters following the Seldinger technique. Dedicated catheter introduction needles are also used in a variety of intravascular introducers (e.g., peripheral, midline, central venous) and also in catheterization procedure kits and trays (e.g., peritoneal dialysis, spinal catheterization, angiography, intravascular).
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