Filtryzer Dialyzer, Capillary, Hollow Fiber

• 2 recalls, same reason

  • Terminated Z-0351-04 FDA Unclassified (pre-2012) ·initiated 30 Dec 2003
  • Terminated Z-0349-04 FDA Unclassified (pre-2012) ·initiated 30 Dec 2003

  Potential loose header (end cap) on hollow fiber dialyzers.

Full name

Filtryzer(Tm)

510(k) Number

K935471 ↗

FDA Product Code

FJI

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Toraysulfone Dialyzer

  Class II

  FDA 510(k) K002512 Active Cleared 15 Oct 2001

• Filtryzer

  Class II

  FDA 510(k) K942681 Active Cleared 22 Jun 1995

• Toray Anthron Angiographic Catheters

  Class II

  FDA 510(k) K872983 Active Cleared 20 Nov 1987

• Toray Superselective Guidewires, Additional Types

  Class II

  FDA 510(k) K874542 Active Cleared 7 Mar 1988

• Toray Superselective Guidewire, Superselec Y-K Type

  Class II

  FDA 510(k) K861115 Active Cleared 11 Jul 1986

• Anthron Catheters & Sets

  Class II

  FDA 510(k) K861117 Active Cleared 18 Jun 1986

See all devices from Toray Industries (America), Inc. →

• What is the Filtryzer used for in medical treatments?

  The Filtryzer is a hollow fiber dialyzer designed specifically for hemofiltration and related extracorporeal blood purification therapies. It filters blood by removing waste products, excess fluids, and electrolytes, making it essential for patients with acute or chronic renal failure in critical care settings like dialysis units or intensive care units.

• Is the Filtryzer intended for single-use or reuse?

  The Filtryzer is supplied as a single-use, sterile disposable device. This design ensures patient safety and sterility, as reuse could compromise the integrity of the semipermeable membrane and introduce contamination risks.

• What regulatory pathway and clearance does the Filtryzer follow?

  The Filtryzer received FDA 510K clearance (K935471) under the Traditional pathway, with regulatory oversight for Gastroenterology and Urology applications. It is classified under FDA product code FJI and is substantially equivalent to its predicate device.

• How should the Filtryzer be stored to maintain functionality?

  The Filtryzer must be stored and handled according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage conditions prevent damage to the hollow fiber membrane and ensure the device remains effective for its intended use in controlled clinical environments.

• What types of clinical environments use the Filtryzer?

  The Filtryzer is intended for use in controlled clinical settings such as dialysis units and intensive care units. These environments ensure proper handling, sterility, and adherence to medical protocols required for hemofiltration therapies.