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FDA 510(k)

Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)

K-Number: K260043 · 2026-02-23

ApplicantSmart Reactors
Decision Date2026-02-23
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Smart Reactors. The 510(k) number is K260043.

When was Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) approved by the FDA?

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

What company makes Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)?

Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) is manufactured by Smart Reactors.

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.

Related Clinical Trials

NCT06336655 Physiology of Unloading VA ECMO Trial RECRUITING NCT05588011 Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass COMPLETED NCT05487612 MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS) RECRUITING

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Official Source

View on FDA Database →

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

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