Toraysulfone Dialyzer

• • Terminated Z-0352-04 FDA Unclassified (pre-2012) ·initiated 30 Dec 2003 ·on shared 510(k) K002512

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K002512 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Filtryzer

  Class II

  FDA 510(k) K942681 Active Cleared 22 Jun 1995

• Filtryzer Dialyzer, Capillary, Hollow Fiber

  Class II

  FDA 510(k) K935471 Active Cleared 19 May 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 Toraysulfone Dialyzer used for?

  The Toraysulfone Dialyzer is a high permeability hemodialysis device designed for high flux dialysis treatment, providing enhanced removal performance for low molecular weight proteins such as β2-MG, and is particularly suitable for HDF treatment.

• Is the Toraysulfone Dialyzer single-use or reusable?

  The Toraysulfone Dialyzer is supplied as a single-use product, ensuring sterility and safety for each patient treatment while eliminating the need for cleaning and sterilization procedures between uses.

• What models and sizes are available for the Toraysulfone Dialyzer?

  The device is available in various models and sizes as indicated by the BS-L series designation, allowing healthcare providers to select the appropriate configuration based on patient needs and treatment requirements.

• What is the regulatory status of the Toraysulfone Dialyzer?

  The Toraysulfone Dialyzer is classified as a Class 2 medical device in the Gastroenterology and Urology specialty and received FDA 510(k) clearance with K number K002512 on October 15, 2001.