LOW PROFILE STEERABLE-INTRAOPERATIVE

LOW PROFILE STEERABLE-INTRAOPERATIVE is an FDA 510(k)-cleared medical device (K833248) 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 21, 1983. Regulation: 8.