Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters

Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters is an FDA 510(k)-cleared medical device (K150514) manufactured by C.R. Bard, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2015. Regulation: 8.