Arteriovenous Blood Tubing Set

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Arteriovenous Blood Tubing Set for

510(k) Number

K823881 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Minicon Concentrator

  Class I

  FDA 510(k) K760592 Active Cleared 23 Nov 1976

• Amicon Minifilter Plus Hemofilter

  Class II

  FDA 510(k) K895405 Active Cleared 11 Jan 1990

• Amicon Diafilters 20 & 30 Hemofilters

  Class II

  FDA 510(k) K823288 Active Cleared 16 Dec 1982

• Amicon Hemoconcentrator Set

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  FDA 510(k) K901286 Active Cleared 18 May 1990

• Centriprep 100

  Class I

  FDA 510(k) K900280 Active Cleared 16 Feb 1990

• Minifilter Hemofilter

  Class II

  FDA 510(k) K853510 Active Cleared 12 Sep 1985

See all devices from Amicon, Inc. →

• What is the primary purpose of this arteriovenous blood tubing set in a clinical setting?

  This tubing set is specifically designed to facilitate the transfer of blood between arterial and venous pathways during hemodialysis procedures. It connects a patient to a high-permeability dialyzer system, ensuring controlled blood flow and proper circulation while the blood is filtered and purified as part of renal replacement therapy.

• Is this tubing set reusable or intended for single-use only, and how should it be stored?

  The tubing set is strictly for single-use only and must not be reused or used on multiple patients. To maintain sterility, it should be stored in clean, dry conditions, away from direct light or moisture, until use.

• Can this tubing set be used in an MRI environment, and what are the storage requirements?

  No, this tubing set is explicitly not intended for MRI use. Storage must be in a clean, dry environment to preserve sterility, as per manufacturer guidelines.

• What regulatory pathway was followed for FDA clearance, and what classification does it hold?

  The device underwent a traditional 510(k) clearance process through the FDA, classified as a Class II medical device under regulation 876.5860. It was determined to be *substantially equivalent* to a predicate device and received clearance under K-number K823881.

• Are there any specific handling instructions regarding its use in dialysis centers?

  Yes, compliance with the manufacturer’s instructions is mandatory for safe and effective operation. The tubing set must be used in regulated environments like dialysis centers or hospitals, and it should only be handled under sterile conditions to prevent contamination.