Cleared Traditional

TruWave Disposable Pressure Transducer

K183413 · Edwards Lifeciences, LLC · Cardiovascular
May 2019
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K183413 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 Lifeciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 1, 2019, 142 days after receiving the submission on December 10, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K183413 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2018
Decision Date May 01, 2019
Days to Decision 142 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