REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER

REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER is an FDA 510(k)-cleared medical device (K121913) 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 December 19, 2012. Regulation: 8.