XO Score Percutaneous Transluminal Angioplasty Scoring Catheter

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is an FDA 510(k)-cleared medical device (K193495) manufactured by Transit Scientific. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2020. Regulation: 8.