Arc Trauma, LLC - FDA 510(k) Cleared Devices

Arc Trauma, LLC is a medical device company based in Jamestown, Ohio, specializing in innovative point-of-injury solutions for traumatic injuries. The company develops life-saving devices designed to manage critical vascular emergencies in high-risk situations.

Arc Trauma has received 1 FDA 510(k) clearance from 1 total submission, with all submissions focused on Cardiovascular devices. The company achieved its first and latest clearance in 2025, demonstrating active regulatory engagement and current market presence.

The company's flagship device addresses arterial restriction in traumatic neck injuries and has undergone rigorous cadaveric perfusion testing and clinical validation. Arc Trauma's multidisciplinary team includes engineers, surgeons, paramedics, perfusionists, and military experts collaborating on evidence-based device development.

Explore the company's cleared device names, product codes, and detailed clearance dates in the FDA 510(k) database.