Provisio Medical, Inc.

Provisio Medical, Inc. specializes in cardiovascular medical devices, primarily intravascular ultrasound (IVUS) imaging catheters designed for single-use procedures. Their portfolio also includes standalone ultrasound imaging systems, such as display units, pulser receiver units, and support crossing catheters. These devices are specifically engineered for real-time visualization of blood vessels and coronary arteries during interventional cardiology procedures.

Provisio Medical, Inc. is headquartered in the United States, which means its devices are subject to FDA regulatory oversight. Since the company’s products fall under FDA Class II classification, they must comply with the agency’s clearance pathways, including the 510(k) premarket notification process and Unique Device Identifier (UDI) requirements. This classification reflects a moderate risk level, necessitating compliance with specific FDA guidelines to ensure safety and effectiveness.

Provisio Medical, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) registry documents premarket submissions proving that a device is substantially equivalent to a legally marketed predicate device, while the UDI registry ensures standardized identification for tracking and traceability. These registries help healthcare providers, regulators, and manufacturers verify compliance and traceability of the devices in the market.

Provisio Medical, Inc.’s devices are classified as FDA Class II, which indicates they pose a moderate risk to patients. This classification requires compliance with special controls, such as performance standards, labeling requirements, and post-market surveillance, in addition to general controls like manufacturing quality systems. Class II devices must undergo a 510(k) clearance process to demonstrate safety and effectiveness before entering the market, ensuring they meet regulatory standards for their intended use.