Device Type: Cardiovascular - Diagnostic
FDA Description:
A percutaneous catheter is a Class II medical device commonly used for therapeutic or diagnostic purposes. It is designed for minimally invasive access to the vascular or other bodily systems. The catheter is regulated under the FDA's Code of Federal Regulations (CFR) for medical devices. Most percutaneous catheters require FDA 510(k) clearance due to their intended use and potential risks, ensuring safety and effectiveness.
General Description:
A percutaneous catheter is a thin, flexible medical device used for accessing blood vessels, delivering medications, or facilitating drainage during minimally invasive procedures. This device is an essential tool in interventional medicine, including cardiology, oncology, and nephrology. It is inserted through the skin (percutaneous entry) and guided to the desired location using advanced imaging techniques.
Percutaneous catheters are typically made from biocompatible materials such as medical-grade plastics and silicone, ensuring flexibility, durability, and patient safety. These materials are often combined with radiopaque markers to enhance visibility during imaging. The device may be used as part of a system, connecting to external components such as syringes, infusion pumps, or monitoring devices.
The design prioritizes sterility, ease of use, and compatibility with various clinical settings. Depending on its intended use, the catheter may include additional features such as side ports, specialized coatings to reduce friction, or integrated guidewires for enhanced maneuverability. Due to its versatility and critical role in patient care, the percutaneous catheter is a staple in modern medical practice.