Device Type: Cardiovascular - Diagnostic
FDA Description:
A flow-directed catheter is a Class II medical device used primarily for measuring cardiac output and other hemodynamic parameters. It is commonly employed in critical care and surgical settings to assess cardiovascular function. The catheter is designed to navigate through blood vessels to specific anatomical locations using blood flow as a guide.
General Description:
A flow-directed catheter is a specialized medical device used to measure hemodynamic parameters, such as cardiac output, pulmonary artery pressure, and oxygen saturation. It is widely utilized in critical care, emergency medicine, and surgical settings to assess cardiovascular function and guide patient management. The catheter is designed to navigate through the vascular system using blood flow as a guide, reaching specific anatomical locations like the pulmonary artery without the need for fluoroscopic guidance.
Constructed from flexible, medical-grade plastic, the catheter is equipped with a balloon at its distal tip, which inflates to allow blood flow to direct its path. This feature minimizes trauma to blood vessels and ensures precise placement. Some flow-directed catheters also include additional lumens for infusing medications, drawing blood samples, or measuring pressures at various sites.
The device is sterile, single-use, and available in different sizes to accommodate various patient anatomies and clinical needs. Flow-directed catheters are rigorously tested for biocompatibility, flexibility, and durability to meet stringent regulatory standards. Their versatility and precision make them indispensable in monitoring critically ill patients, optimizing treatments, and improving clinical outcomes.