Vascutek, Ltd. - FDA 510(k) Cleared Devices

Vascutek, Ltd. is a global medical device company committed to developing innovative solutions for aortic and peripheral vascular disease. The company operates with a manufacturing facility in Inchinnan, Renfrewshire, Scotland. Now part of Terumo Aortic, the brand continues to advance cardiovascular care worldwide.

Vascutek has a strong FDA 510(k) regulatory track record. The company has received 23 FDA 510(k) clearances from 26 total submissions since its first clearance in 1991. All submissions focus on Cardiovascular devices, reflecting the company's specialization in aortic and vascular solutions. The latest clearance in 2025 demonstrates continued innovation and active regulatory engagement.

The company's portfolio includes surgical grafts, endovascular stent-grafts, and hybrid solutions. Products span woven vascular prostheses, branched grafts with advanced features, and specialized patch materials. These devices address complex aortic anatomy across the full spectrum of surgical, endovascular, and hybrid repair approaches.

Explore the complete list of device names, product codes, and individual clearance dates in the FDA 510(k) database.

Regulatory submissions have been managed by Bolton Medical, Inc. (Dba Terumo Aortic) and Bolton Medical Inc. (Dba Terumo Aortic).