exGraft, exGraft Carbon ePTFE Vascular Grafts

exGraft, exGraft Carbon ePTFE Vascular Grafts is an FDA 510(k)-cleared medical device (K180957) manufactured by Peca Labs. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 2018. Regulation: 8.