CPS Direct™ Universal slittable outer guide catheter (DS2C029)

CPS Direct™ Universal slittable outer guide catheter (DS2C029) is an FDA 510(k)-cleared medical device (K231311) manufactured by ABBOTT 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 June 1, 2023. Regulation: 8.