THE CROSSER 14 OTW CATHETER, MODEL CRU014

THE CROSSER 14 OTW CATHETER, MODEL CRU014 is an FDA 510(k)-cleared medical device (K091254) manufactured by Flowcardia, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2009. Regulation: 8.