Volcarica S.R.L.

Volcarica S.R.L. specializes in intravascular diagnostic devices. Their primary products include single-use intravascular ultrasound (IVUS) imaging catheters, which provide real-time imaging of blood vessels, and catheter-tip transducers designed to measure pressure within coronary and peripheral arteries. These devices support interventional cardiology and vascular assessments by delivering critical imaging and hemodynamic data during procedures.

Volcarica S.R.L. is based in the United States, which means its devices must comply with U.S. medical device regulations. Since their products fall under Class II classification—requiring performance standards and post-market surveillance—they align with FDA requirements for diagnostic and interventional tools used in coronary and peripheral vascular procedures.

Volcarica S.R.L.’s devices are included in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify device details such as model names, classifications, and regulatory status. Listing in the UDI system is mandatory for Class II devices in the U.S.

Volcarica S.R.L.’s devices are classified as Class II under FDA regulations. This classification applies to devices that pose moderate risk and require special controls—such as performance standards, labeling requirements, or post-market surveillance—to ensure safety and effectiveness. Intravascular ultrasound catheters and pressure guide wires fall into this category due to their role in diagnostic and interventional procedures.