FDA 510(k)

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

Número K: K242503 · 2025-11-24

Data da decisão2025-11-24

Código do produtoDTZ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) 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 2025-11-24 under 510(k) number K242503. 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 Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Eurosets S.R.L. The 510(k) number is K242503.

When did Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) receive FDA 510(k) clearance?

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) received FDA 510(k) clearance on 2025-11-24, under 510(k) number K242503.

Who is the listed applicant for Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?

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 Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?

The FDA product code for Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is DTZ.

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

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)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)K202510AMG PMP Bebê K202206AMG PMP Pediátrico

Dispositivos Relacionados (Código: DTZ)

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L 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 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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