LEMAITRE BALLOON CATHETER WITH IRRIGATION

LEMAITRE BALLOON CATHETER WITH IRRIGATION is an FDA 510(k)-cleared medical device (K992940) manufactured by Vascutech, 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 21, 2000. Regulation: 8.