REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER is an FDA 510(k)-cleared medical device (K063076) manufactured by Ascent Healthcare Solutions. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2007. Regulation: 8.