exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts is an FDA 510(k)-cleared medical device (K233783) manufactured by Peca Labs, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2024. Regulation: 8.