TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED

TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED is an FDA 510(k)-cleared medical device (K915521) manufactured by Target Therapeutics. 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 22, 1992. Regulation: 8.