Device Type: Cardiovascular - Diagnostic
FDA Description:
A wire-guided catheter is a Class II medical device used in minimally invasive procedures to navigate through blood vessels, delivering or retrieving diagnostic or therapeutic instruments. It includes a flexible catheter and a guidewire, ensuring precise placement. The FDA requires compliance with safety and performance standards for this device.
General Description:
A wire-guided catheter is a medical device commonly used in minimally invasive procedures to facilitate the navigation of blood vessels. It consists of a flexible, hollow catheter and a guidewire, which work together to ensure precise placement of the catheter in the desired location. This device is instrumental in procedures such as angioplasty, stent placement, and the delivery of contrast agents for imaging studies.
The guidewire is typically made from metal alloys such as stainless steel or nitinol, providing strength and flexibility to traverse complex vascular pathways. The catheter, made from medical-grade plastics, is designed to be compatible with the guidewire, offering a smooth interface to minimize friction during insertion and manipulation.
Wire-guided catheters are available in various lengths, diameters, and configurations to suit specific clinical applications and patient anatomies. Their design emphasizes control, safety, and efficiency, allowing clinicians to navigate narrow or tortuous vessels while reducing the risk of vessel trauma.
These devices are rigorously tested to meet FDA standards, ensuring safety, biocompatibility, and functionality. They are indispensable in interventional cardiology, radiology, and vascular surgery, offering a reliable tool for delivering precise and effective treatment in minimally invasive procedures.