Flextra Steerable Introducer

Flextra Steerable Introducer is an FDA 510(k)-cleared medical device (K170373) manufactured by Rhythm Xience, Inc. (Rxi). This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 2017. Regulation: 8.