1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME

1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME is an FDA 510(k)-cleared medical device (K140042) manufactured by LeMaitre Vascular, 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 April 9, 2014. Regulation: 8.