EV1000 CLINICAL PLATFORM— 510(k) K131892

Name: FDA 510(k) clearance K131892
Creator: U.S. Food and Drug Administration
Published: 2014-05-22

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K131892 for EV1000 CLINICAL PLATFORM, Substantially Equivalent on 2014-05-22. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2013-06-25
Decision date: 2014-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXG

view all

K253092 — Argos Infinity (Rev. 1.0)2026-02-13
K251275 — VitalStream ART Connect; VitalStream-Hemo2025-09-26
K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS2023-12-20
K212529 — Hypotension Decision Assist Model HDA-OR22021-11-23
K192169 — PulsioFlex Monitoring System with ProAQT Sensor2020-04-30

More clearances from Edwards Lifesciences, LLC

view all

K251326 — Respiration Rate algorithm2026-06-11
K253186 — HemoSphere Nano Monitor (HSNANO1)2026-02-24
K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)2025-09-23
K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)2025-09-17
K242518 — Hypertension Prediction Index (HePI) Algorithm2025-05-15

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