SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter is an FDA 510(k)-cleared medical device (K221832) manufactured by Cordis US Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2022. Regulation: 8.