Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)

N.º K: K260043 · 2026-02-23

SolicitanteSmart Reactors
Fecha de decisión2026-02-23
Código de productoDWF
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: DWF)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.K253106AngioVac CannulaAngioDynamics, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑