CPS Direct MediGuide Enabled outer catheter

CPS Direct MediGuide Enabled outer catheter is an FDA 510(k)-cleared medical device (K142239) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 2014. Regulation: 8.