Infinity Angioplasty Balloon Catheter

Infinity Angioplasty Balloon Catheter is an FDA 510(k)-cleared medical device (K192399) manufactured by Infinity Angioplasty Balloon Company, LLC. 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 19, 2020. Regulation: 8.