REPROCESSED STEERABLE INTRODUCER

REPROCESSED STEERABLE INTRODUCER is an FDA 510(k)-cleared medical device (K123334) manufactured by Stryker Sustainability Solutions, 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 23, 2013. Regulation: 8.