Filtryzer(Tm)

FDA 510(k) K935471 · Toray Industries (America), Inc.

Substantially Equivalent

510(k) numberK935471

Submission

Device name
Filtryzer(Tm)
Applicant
Toray Industries (America), Inc.
Otsu-Shi, Shiga-Ken 520, JP
Received
November 15, 1993
Decision date
May 19, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FJI – Dialyzer, Capillary, Hollow Fiber
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

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K122952Nipro Pureflux-L HemodialyzerFJI · Traditional Nipro Medical Corporation12/04/2013SE
K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional Gambro Renal Products05/27/2005SE
K010366Disposable Storage CapFJI · Abbreviated Molded Products, Inc.11/28/2001SE
K011148Ultraconcentrator SystemFJI · Special Interpore Cross Intl.06/13/2001SE
K002761Fresnius Hemoflow F7NR, F50NR, F70NR HemodialyzersFJI · Traditional Fresenius Medical Care North America12/04/2000SE
K991908Idemsa Hemophan Hollow Fiber DialyzersFJI · Traditional Idemsa04/17/2000SE
K992594A-15 HemodialyzerFJI · Traditional Althin Medical AB09/24/1999SE
K992565A-18 HemodialyzerFJI · Traditional Althin Medical AB09/23/1999SE
K991512Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional Asahi Medical Co., Ltd.07/29/1999SE

More from Asahi Medical Co., Ltd.

510(k)DeviceDecision
K042370Torayguide GuidewireDQX · Traditional 12/17/2004SE
K030050Toraysulfone Dialyzer, Bs-L SeriesKDI · Traditional 09/29/2003SE
K002512Toraysulfone DialyzerKDI · Traditional 10/15/2001SE
K994198Hemofeel-Ch, Models CH-0.35L, CH-0.6L, CH-1.0LKDI · Traditional 08/25/2000SE
K942681FiltryzerKDI · Traditional 06/22/1995SE
K940910FiltryzerFJI · Traditional 05/04/1995SE
K884339Toray Filtryzer DialyzersFJI · Traditional 03/17/1989SE
K883407Toray Filtryzer BK SeriesKDI · Traditional 02/27/1989SE
K884083Toray Vascular ProsthesisDSY · Traditional 01/12/1989SE
K882158Modified Toray Filtryzer DialyzersFJI · Traditional 08/12/1988SE

Questions and answers

When was Filtryzer(Tm) cleared by the FDA?

Filtryzer(Tm) (K935471) received a 510(k) decision of Substantially Equivalent on May 19, 1995, 550 days after the submission was received.

What is the product code of K935471?

The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.