OUTBACK Elite Re-Entry Catheter

OUTBACK Elite Re-Entry Catheter is an FDA 510(k)-cleared medical device (K150836) manufactured by Cordis Corporation, A Johnson & Johnson Co.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 2015. Regulation: 8.