TruWave Disposable Pressure Transducer

TruWave Disposable Pressure Transducer is an FDA 510(k)-cleared medical device (K183413) manufactured by Edwards Lifeciences, 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 April 30, 2019. Regulation: 8.