FDA 510(k)

Quantum Perfusion Hybrid System

Número K: K241206 · 2024-07-18

Data da decisão2024-07-18

Código do produtoDTN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Quantum Perfusion Hybrid System is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K241206. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Quantum Perfusion Hybrid System?

Quantum Perfusion Hybrid System is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K241206.

When did Quantum Perfusion Hybrid System receive FDA 510(k) clearance?

Quantum Perfusion Hybrid System received FDA 510(k) clearance on 2024-07-18, under 510(k) number K241206.

Who is the listed applicant for Quantum Perfusion Hybrid System?

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

What is the FDA product code for Quantum Perfusion Hybrid System?

The FDA product code for Quantum Perfusion Hybrid System is DTN.

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

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);K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

Dispositivos Relacionados (Código: DTN)

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241053Bolsa de Reservatório Venoso MVR™ 800 mL; Bolsa de Reservatório Venoso MVR™ 1600 mL; Bolsa de Reservatório Venoso MVR™ com Superfície Bioativa Cortiva™ 800 mL; Bolsa de Reservatório Venoso MVR™ com Superfície Bioativa Cortiva™ 1600 mLMedtronic Cardiac Surgery K223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.

Fonte oficial

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