ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION

ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION is an FDA 510(k)-cleared medical device (K922787) manufactured by Echocath, 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 5, 1993. Regulation: 8.