SABER .035 PTA Dilatation Catheter

SABER .035 PTA Dilatation Catheter is an FDA 510(k)-cleared medical device (K201333) manufactured by Cordis Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2020. Regulation: 8.