DISPOSABLE OPTICAL VALVULOTOME

DISPOSABLE OPTICAL VALVULOTOME is an FDA 510(k)-cleared medical device (K924075) manufactured by Endovascular, 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 February 7, 1993. Regulation: 8.