Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) is an FDA 510(k)-cleared medical device (K250105) manufactured by Aveera Medical, 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 July 2, 2025. Regulation: 8.