STEALTH DILATION CATHETER SYSTEM (MODIFIED)

STEALTH DILATION CATHETER SYSTEM (MODIFIED) is an FDA 510(k)-cleared medical device (K915895) manufactured by Target Therapeutics. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 1992. Regulation: 8.