Cleared Traditional

TruWave Disposable Pressure Transducer

K222216 · Edwards Lifesciences, LLC · Cardiovascular
Dec 2022
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K222216 is an FDA 510(k) clearance for the TruWave Disposable Pressure Transducer, a Transducer, Pressure, Catheter Tip (Class II — Special Controls, product code DXO), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on December 22, 2022, 150 days after receiving the submission on July 25, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K222216 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2022
Decision Date December 22, 2022
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXO — Transducer, Pressure, Catheter Tip
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2870