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CardioQ-EDM, CardioQ-EDM+

by Deltex Medical Limited

510(k) K150347

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150347↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK150347 Date24 Jul 2015ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
510(k) Number
FDA Product Code
DPW
Device Class
Class II
Regulation
21 CFR Part 870.2100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CardioQ-EDM and CardioQ-EDM+ are blood flowmeters designed for cardiovascular applications. These devices measure and monitor blood flow in real-time, providing critical data for assessing cardiac performance and haemodynamic status in clinical settings. They are classified as Class II devices under the FDA and fall under the medical specialty of cardiovascular diagnostics.

The CardioQ-EDM and CardioQ-EDM+ are intended for use in hospital or clinical environments, where they are connected to patients via arterial catheters to measure cardiac output and other haemodynamic parameters. Supplied as reusable medical devices, they comply with the Medical Device Directive (MDD) and have received FDA 510(k) clearance as substantially equivalent to predicate devices. No specific sterility or MRI safety information is provided in the data, and sizes or additional technical specifications are not detailed beyond their classification as flowmeters.

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