ACS URETHAN CORONARY GUIDING CATHETER

ACS URETHAN CORONARY GUIDING CATHETER is an FDA 510(k)-cleared medical device (K904884) 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 January 2, 1991. Regulation: 8.