PTS-X SIZING BALLOON CATHETER

PTS-X SIZING BALLOON CATHETER is an FDA 510(k)-cleared medical device (K110903) manufactured by NuMED, 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 28, 2011. Regulation: 8.