VisionAir Patient-Specific Airway Stent

VisionAir Patient-Specific Airway Stent is an FDA 510(k)-cleared medical device (K213969) manufactured by New Cos Inc. Dba Visionair Solutions. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 2022. Regulation: 8.