SCANLAN/TAHERI VALVULOTOME

SCANLAN/TAHERI VALVULOTOME is an FDA 510(k)-cleared medical device (K911184) manufactured by Scanlan Intl., 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 17, 1992. Regulation: 8.