Filtryzer

• • Terminated Z-0350-04 FDA Unclassified (pre-2012) ·initiated 30 Dec 2003

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

510(k) Number

K940910 ↗

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

• 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

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