Vycor Medical, Inc.

Vycor Medical, Inc. specializes in neurosurgical retraction cannulas, with a primary focus on the ViewSite Brain Access System and its variants, such as the system with alignment clips. These devices are engineered to assist in minimally invasive brain access procedures, helping surgeons perform precise interventions with reduced tissue trauma.

Vycor Medical, Inc. is headquartered in the United States. Its devices are regulated in both the EU and the US, as evidenced by listings in the EU’s eudamed database and the FDA’s systems, including the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. This reflects compliance with regional medical device regulations.

Vycor Medical’s devices are included in the EU’s eudamed database, which tracks medical devices authorized in the European Economic Area. In the US, they appear in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system, demonstrating their regulatory status in both regions.

Vycor Medical’s devices fall under both Class II and Class III classifications. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices are higher risk and typically require premarket approval due to insufficient data from lesser classifications. The specific classification depends on the device’s intended use and potential risk profile.