SOFTTOUCH(R) GUIDING CATHETER

SOFTTOUCH(R) GUIDING CATHETER is an FDA 510(k)-cleared medical device (K912199) manufactured by Mallinckrodt Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 1991. Regulation: 8.