Guider Catheter Introducer

Guider Catheter Introducer is an FDA 510(k)-cleared medical device (K171081) 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 May 8, 2017. Regulation: 8.