FDA 510(k)

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

Número K: K261438 · 2026-09-14

Data da decisão2026-09-14

Código do produtoDTZ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Eurosets S.R.L como candidato(a)

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 Bebê K202206AMG PMP Pediátrico

Dispositivos Relacionados (Código: DTZ)

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.L K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L K240666Oxigenador Affinity Fusion com Filtro Arterial Integrado e Balance Biosurface (BB811); Oxigenador Affinity Fusion com Filtro Arterial Integrado e Cardiotomy/Venous Reservoir com Balance Biosurface (BB841); Oxigenador Affinity Fusion com Filtro Arterial Integrado e Balance Biosurface NÃO ESTÉRIL (BB811-NS)Medtronic Perfusion Systems

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