TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES

TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES is an FDA 510(k)-cleared medical device (K911605) 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 July 8, 1991. Regulation: 8.