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FDA 510(k)

Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)

Número K: K260043 · 2026-02-23

RequerenteSmart Reactors
Data da decisão2026-02-23
Código do produtoDWF
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) is the device name listed in this FDA 510(k) record. The listed applicant is Smart Reactors. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K260043. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)?

Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Smart Reactors. The 510(k) number is K260043.

When did Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) receive FDA 510(k) clearance?

Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) received FDA 510(k) clearance on 2026-02-23, under 510(k) number K260043.

Who is the listed applicant for Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)?

The FDA 510(k) record lists Smart Reactors as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)?

The FDA product code for Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) is DWF.

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