TRANSLUMINAL ENDARTERECTOMY DEVICE

TRANSLUMINAL ENDARTERECTOMY DEVICE is an FDA 510(k)-cleared medical device (K904944) manufactured by Baxter Healthcare Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 1990. Regulation: 8.