FOGARTY VALVULOTOME MODEL 700091

FOGARTY VALVULOTOME MODEL 700091 is an FDA 510(k)-cleared medical device (K965137) manufactured by Baxter Edwards. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 1997. Regulation: 8.