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FDA 510(k)

CAREline Airless Hemodialysis Blood Tubing Sets

N.º K: K172238 · 2017-12-14

SolicitanteFresenius Medical Care Renal Therapies Group, LLC
Fecha de decisión2017-12-14
Código de productoKOC
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

CAREline Airless Hemodialysis Blood Tubing Sets is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K172238. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CAREline Airless Hemodialysis Blood Tubing Sets?

CAREline Airless Hemodialysis Blood Tubing Sets is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K172238.

When did CAREline Airless Hemodialysis Blood Tubing Sets receive FDA 510(k) clearance?

CAREline Airless Hemodialysis Blood Tubing Sets received FDA 510(k) clearance on 2017-12-14, under 510(k) number K172238.

Who is the listed applicant for CAREline Airless Hemodialysis Blood Tubing Sets?

The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAREline Airless Hemodialysis Blood Tubing Sets?

The FDA product code for CAREline Airless Hemodialysis Blood Tubing Sets is KOC.

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Otros registros que enlistan a Fresenius Medical Care Renal Therapies Group, LLC como solicitante

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Dispositivos relacionados (Código: KOC)

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.

K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PUNIKKISO CO., LTD.K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)NIKKISO CO., LTD.K231589Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD.K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNIKKISO CO., LTD.K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineFresenius Medical Care Renal Therapies Group, LLCK160749CRIT-LINE III Blood Chamber IIFresenius Medical Care Renal Therapies Group, LLC

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.

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