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Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)

by Eurosets S.R.L.

510(k) K250821

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250821↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250821 Date12 Dec 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DTZ
Models / Variants
FDA applicant
Eurosets S.R.L
Device Class
Class II
Regulation
21 CFR Part 870.4350
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 Horizon AF Plus System comprises an integrated cardiopulmonary bypass oxygenator and a venous reservoir designed for use during open-heart surgical procedures. The A.L. One AF Plus Oxygenator (US5204) facilitates gas exchange and blood oxygenation, while the Horizon CVR (US5073) serves as a venous reservoir to manage blood volume and temperature during extracorporeal circulation. Both components are engineered to support prolonged cardiac arrest and complex cardiac interventions, adhering to cardiovascular device nomenclature standards.

This system is intended for single-use in controlled clinical environments such as operating rooms and cardiac catheterization labs. Supplied sterile and pre-packaged, it requires no additional sterilization and must be discarded after one use. The devices are classified as Class II under FDA regulations and comply with MDR (Medical Device Regulation) standards. Sizes and configurations are standardized for compatibility with existing cardiopulmonary bypass circuits, with no MRI safety considerations specified.

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Questions

AI-generated answers, 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.

  • What clinical procedures is the Horizon AF Plus System designed to support during open-heart surgeries?

    The Horizon AF Plus System is specifically engineered to support prolonged cardiac arrest and complex cardiac interventions during open-heart surgical procedures. It combines an oxygenator for gas exchange and blood oxygenation with a venous reservoir to manage blood volume and temperature, making it suitable for extended extracorporeal circulation needs in cardiac surgery.

  • How is the Horizon AF Plus System supplied, and what are the handling requirements?

    The system is supplied sterile and pre-packaged, requiring no additional sterilization before use. It is intended for single-use only in controlled clinical environments like operating rooms or cardiac catheterization labs. After use, the entire system must be discarded to ensure patient safety and sterility.

  • Are there different sizes or models available for the Horizon AF Plus System, and how do they integrate with existing equipment?

    The Horizon AF Plus System includes standardized sizes and configurations for both the A.L. One AF Plus Oxygenator and the Horizon CVR, ensuring compatibility with existing cardiopulmonary bypass circuits. While exact sizing details aren’t specified, the design adheres to cardiovascular device standards to facilitate seamless integration with standard clinical setups.

  • What regulatory pathways does the Horizon AF Plus System follow, and how does this affect its use?

    The system follows both FDA 510(k) clearance and EU MDR compliance pathways. The FDA categorizes it as a Class II device under the substantial equivalence determination (SESE), while it meets EU Medical Device Regulation (MDR) standards. These pathways ensure it meets stringent safety and performance requirements for use in clinical settings.

  • Can the Horizon AF Plus System be reused, or is it strictly for single-use?

    The Horizon AF Plus System is explicitly designed for single-use only. After a single procedure, the entire system must be discarded to maintain sterility and prevent cross-contamination, aligning with best practices for medical devices in controlled clinical environments like operating rooms.