ENDOSONICS TRAK BACK DEVICE

ENDOSONICS TRAK BACK DEVICE is an FDA 510(k)-cleared medical device (K990271) manufactured by Endosonics Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 29, 1999. Regulation: 8.