CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC

CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC is an FDA 510(k)-cleared medical device (K131079) manufactured by Creganna Medical Devices. 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 31, 2013. Regulation: 8.