510(k) K141495

TRUWAVE DISPOSABLE PRESSURE TRANSDUCER by Edwards Lifesciences, LLC — Product Code DXO

K141495 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "TRUWAVE DISPOSABLE PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on September 3, 2014. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.