SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT

SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT is an FDA 510(k)-cleared medical device (K094044) manufactured by Tayside Flow Technologies Limited. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 2010. Regulation: 8.