Medical Device Manufacturer · GB , Pa49rr Scotland

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

26 submissions · 23 cleared · Since 1991

Total

Cleared

Denied

26 devices

26-26 of 26

Regulatory consultants 510(k) submission support ecosystem

Bolton Medical, Inc. (Dba Terumo Aortic)

Bolton Medical Inc. (Dba Terumo Aortic)

Regulatory activity signals

510(k) clearance pathway relevance detected
Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026