FDA 510(k)

Blood Tubing Lines for Hemodialysis AV06C-E

K-Number: K231589 · 2023-07-28

Decision Date2023-07-28

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Blood Tubing Lines for Hemodialysis AV06C-E is a medical device manufactured by NIKKISO CO., LTD.. It received FDA 510(k) clearance on 2023-07-28 under approval number K231589. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blood Tubing Lines for Hemodialysis AV06C-E?

Blood Tubing Lines for Hemodialysis AV06C-E is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by NIKKISO CO., LTD.. The 510(k) number is K231589.

When was Blood Tubing Lines for Hemodialysis AV06C-E approved by the FDA?

Blood Tubing Lines for Hemodialysis AV06C-E received FDA 510(k) clearance on 2023-07-28, under approval number K231589.

What company makes Blood Tubing Lines for Hemodialysis AV06C-E?

Blood Tubing Lines for Hemodialysis AV06C-E is manufactured by NIKKISO CO., LTD..

What is the FDA product code for Blood Tubing Lines for Hemodialysis AV06C-E?

The FDA product code for Blood Tubing Lines for Hemodialysis AV06C-E is KOC.

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Related PubMed Literature

PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Other Devices by NIKKISO CO., LTD.

K152938DBB-06 Hemodialysis Delivery System K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series 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-PU 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)

Related Devices (Code: KOC)

K160749CRIT-LINE III Blood Chamber IIFresenius Medical Care Renal Therapies Group, LLC K172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC 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, LLC K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNIKKISO CO., LTD. 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.

Official Source

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