URESIL DILATOR WITH RADIOPAQUE MARKER

URESIL DILATOR WITH RADIOPAQUE MARKER is an FDA 510(k)-cleared medical device (K980282) 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 April 23, 1998. Regulation: 8.