OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120

OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 is an FDA 510(k)-cleared medical device (K083814) manufactured by Cordis Corp., 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 January 12, 2009. Regulation: 8.