Toray Filtryzer Dialyzers
FDA 510(k) K884339 · Toray Industries (America), Inc.
510(k) numberK884339
Submission
- Device name
- Toray Filtryzer Dialyzers
- Applicant
- Toray Industries (America), Inc.
New York, NY, US - Received
- October 14, 1988
- Decision date
- March 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code FJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190459 | Hemoflow F3 and F4 DialyzersFJI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/23/2019SE |
| K122952 | Nipro Pureflux-L HemodialyzerFJI · Traditional | Nipro Medical Corporation | 12/04/2013SE |
| K043342 | Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional | Gambro Renal Products | 05/27/2005SE |
| K010366 | Disposable Storage CapFJI · Abbreviated | Molded Products, Inc. | 11/28/2001SE |
| K011148 | Ultraconcentrator SystemFJI · Special | Interpore Cross Intl. | 06/13/2001SE |
| K002761 | Fresnius Hemoflow F7NR, F50NR, F70NR HemodialyzersFJI · Traditional | Fresenius Medical Care North America | 12/04/2000SE |
| K991908 | Idemsa Hemophan Hollow Fiber DialyzersFJI · Traditional | Idemsa | 04/17/2000SE |
| K992594 | A-15 HemodialyzerFJI · Traditional | Althin Medical AB | 09/24/1999SE |
| K992565 | A-18 HemodialyzerFJI · Traditional | Althin Medical AB | 09/23/1999SE |
| K991512 | Asahi 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) | Device | Decision |
|---|---|---|
| K042370 | Torayguide GuidewireDQX · Traditional | 12/17/2004SE |
| K030050 | Toraysulfone Dialyzer, Bs-L SeriesKDI · Traditional | 09/29/2003SE |
| K002512 | Toraysulfone DialyzerKDI · Traditional | 10/15/2001SE |
| K994198 | Hemofeel-Ch, Models CH-0.35L, CH-0.6L, CH-1.0LKDI · Traditional | 08/25/2000SE |
| K942681 | FiltryzerKDI · Traditional | 06/22/1995SE |
| K935471 | Filtryzer(Tm)FJI · Traditional | 05/19/1995SE |
| K940910 | FiltryzerFJI · Traditional | 05/04/1995SE |
| K883407 | Toray Filtryzer BK SeriesKDI · Traditional | 02/27/1989SE |
| K884083 | Toray Vascular ProsthesisDSY · Traditional | 01/12/1989SE |
| K882158 | Modified Toray Filtryzer DialyzersFJI · Traditional | 08/12/1988SE |
Questions and answers
When was Toray Filtryzer Dialyzers cleared by the FDA?
Toray Filtryzer Dialyzers (K884339) received a 510(k) decision of Substantially Equivalent on March 17, 1989, 154 days after the submission was received.
What is the product code of K884339?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.