510(k) K183413

TruWave Disposable Pressure Transducer by Edwards Lifeciences, LLC — Product Code DXO

K183413 is an FDA 510(k) premarket notification submitted by Edwards Lifeciences, LLC for the device "TruWave Disposable Pressure Transducer". The FDA issued a decision of Substantially Equivalent on May 1, 2019. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Edwards Lifeciences, LLC has at least 2 other 510(k) clearances on record.