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FDA 510(k)

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

N.º K: K230514 · 2023-06-16

SolicitanteNIKKISO CO., LTD.
Fecha de decisión2023-06-16
Código de productoKOC
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series is the device name listed in this FDA 510(k) record. The listed applicant is NIKKISO CO., LTD.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K230514. 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 Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series?

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is NIKKISO CO., LTD.. The 510(k) number is K230514.

When did Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series receive FDA 510(k) clearance?

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230514.

Who is the listed applicant for Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series?

The FDA 510(k) record lists NIKKISO CO., LTD. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series?

The FDA product code for Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series is KOC.

Ensayos clínicos relacionados

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Otros registros que enlistan a NIKKISO CO., LTD. como solicitante

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.

K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)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-PUK242176BLOOD 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)K231589Blood Tubing Lines for Hemodialysis AV06C-EK152938DBB-06 Hemodialysis Delivery System

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.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, LLCK172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLCK160749CRIT-LINE III Blood Chamber IIFresenius Medical Care Renal Therapies Group, LLC

Fuente oficial

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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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