TYSHAK PERIPHERAL BALLOON DILATION CATHETER

TYSHAK PERIPHERAL BALLOON DILATION CATHETER is an FDA 510(k)-cleared medical device (K931009) 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 December 20, 1993. Regulation: 8.