Maquet Cardiopulmonary AG

Maquet Cardiopulmonary AG specializes in devices used during cardiopulmonary bypass procedures, such as roller-type bypass systems, centrifugal pumps (e.g., ROTAFLOW), and extracorporeal membrane oxygenators (e.g., Cardiohelp). Their portfolio also includes peripheral vascular catheters, blood tubing sets (e.g., HLS Set), air bubble/fluid level detectors, vascular catheter introduction sets, and extracorporeal blood gas/pH monitors (e.g., AVALON ELITE). These products support critical circulatory and respiratory functions in surgical and intensive care settings.

Maquet Cardiopulmonary AG is headquartered in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class II classification, they are authorised through pathways like the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. This ensures compliance with U.S. medical device standards and visibility in FDA databases like the 510(k) and UDI registries.

Maquet Cardiopulmonary AG’s devices are listed in the FDA’s 510(k) and UDI registries because these pathways are required for Class II medical devices in the U.S. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate, while the UDI system ensures traceability and transparency in the supply chain. Listing in these databases confirms the devices meet FDA requirements for safety and performance.

Maquet Cardiopulmonary AG’s devices are classified as Class II under FDA regulations, which means they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification requires manufacturers to follow specific regulatory pathways, such as the 510(k) process, to demonstrate their devices meet performance standards. Class II classification also implies these devices undergo rigorous testing and documentation to support their use in critical medical procedures like cardiopulmonary bypass.

The 510(k) pathway is used for Class II devices to show they are substantially equivalent to a previously authorised device (a predicate) in terms of technology and safety. This pathway is common for devices like Maquet’s cardiopulmonary bypass systems, where equivalence to existing solutions helps streamline the authorisation process while maintaining regulatory oversight. The UDI system is mandatory for all Class II devices to improve tracking, reduce medical errors, and enhance supply chain transparency, ensuring healthcare providers can quickly identify and verify device information.