Pi-Cardia, Ltd.

Pi-Cardia, Ltd. specializes in cardiac valvuloplasty catheters, which are used for balloon dilation of stenotic (narrowed) heart valves. These devices help restore proper blood flow through the valve by mechanically widening the narrowed area, addressing conditions like aortic or pulmonary valve stenosis.

Pi-Cardia, Ltd. is headquartered in the United States. Its devices are classified as Class II medical devices under FDA regulations, meaning they pose moderate risk and require pre-market notification (510(k)) clearance before commercial distribution. Additionally, the company’s products are listed under the FDA’s Unique Device Identification (UDI) system, which ensures traceability and identification of medical devices.

Pi-Cardia, Ltd.’s devices are registered under the FDA’s 510(k) pre-market notification program and the FDA’s Unique Device Identifier (UDI) program. These registries ensure compliance with U.S. medical device regulations and provide transparency on device classification and approval pathways.

Pi-Cardia, Ltd.’s devices are classified as Class II medical devices by the FDA. This classification is based on their intended use—specifically, cardiac valvuloplasty catheters for balloon dilation of stenotic heart valves—which carries a moderate risk. Class II devices require pre-market clearance through the 510(k) process to demonstrate substantial equivalence to a legally marketed predicate device.