ACS TOURGIDE GUIDING CATHETER

ACS TOURGIDE GUIDING CATHETER is an FDA 510(k)-cleared medical device (K953987) manufactured by Advanced Cardiovascular Systems, 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 6, 1995. Regulation: 8.