STEALTH DILATION CATHETER SYSTEM/MODIFICATION

STEALTH DILATION CATHETER SYSTEM/MODIFICATION is an FDA 510(k)-cleared medical device (K904287) 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 January 15, 1991. Regulation: 8.