SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is an FDA 510(k)-cleared medical device (K210626) 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 April 22, 2021. Regulation: 8.