URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS

URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS is an FDA 510(k)-cleared medical device (K930011) manufactured by Uresil Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 1993. Regulation: 8.