TRUWAVE DISPOSABLE PRESSURE TRANSDUCER— 510(k) K141495

Name: FDA 510(k) clearance K141495
Creator: U.S. Food and Drug Administration
Published: 2014-09-03

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K141495 for TRUWAVE DISPOSABLE PRESSURE TRANSDUCER, Substantially Equivalent on 2014-09-03. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXO
Device class: Class 2
Regulation: 21 CFR 870.2870
Advisory panel: Cardiovascular
Date received: 2014-06-06
Decision date: 2014-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXO

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K222216 — TruWave Disposable Pressure Transducer2022-12-22
K202943 — OptoMonitor 32020-11-24

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Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.