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FDA 510(k)

HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)

K-Number: K261438 · 2026-09-14

ApplicantEurosets S.R.L
Decision Date2026-09-14
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) is the device name listed in this FDA 510(k) record. The listed applicant is Eurosets S.R.L. It received FDA 510(k) clearance on 2026-09-14 under 510(k) number K261438. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)?

HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Eurosets S.R.L. The 510(k) number is K261438.

When did HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) receive FDA 510(k) clearance?

HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) received FDA 510(k) clearance on 2026-09-14, under 510(k) number K261438.

Who is the listed applicant for HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)?

The FDA 510(k) record lists Eurosets S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)?

The FDA product code for HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) is DTZ.

Other records listing Eurosets S.R.L as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)K202510AMG PMP InfantK202206AMG PMP Pediatric

Related Devices (Code: DTZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.LK242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.LK231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.LK240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)Medtronic Perfusion Systems

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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