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Blood Tubing Lines for Hemodialysis AV06C-E

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231589

by Nikkiso Co., Ltd.

Identifiers

510(k) Number
K231589 FDA 510(k)
FDA Product Code
KOC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Blood Tubing Lines for Hemodialysis AV06C-E are classified as Accessories, Blood Circuit, Hemodialysis, designed to facilitate the safe and efficient transfer of blood during hemodialysis procedures. These sterile, single-use tubing lines connect the patient’s arteriovenous (AV) fistula or graft to the hemodialysis machine, ensuring proper blood flow and minimizing the risk of contamination or clotting during treatment.

Supplied as sterile, single-use devices, these tubing lines are intended for use in hemodialysis centers and clinical settings where renal replacement therapy is administered. They are regulated under FDA 510(k) clearance and comply with the Medical Device Directive (MDD), with a classification as Class II devices. The AV06C-E model is part of a broader family of hemodialysis accessories, adhering to strict manufacturing and quality standards to ensure reliability and patient safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nikkiso Co., Ltd.

Sources (2)

  • FDA 510(k) K231589 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026