ACS POWERBASE(TM) CORONARY GUIDING CATHETER

ACS POWERBASE(TM) CORONARY GUIDING CATHETER is an FDA 510(k)-cleared medical device (K940559) 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 May 2, 1994. Regulation: 8.