Toraysulfone Dialyzer, Bs-L Series
FDA 510(k) K030050 · Toray Industries (America), Inc.
510(k) numberK030050
Submission
- Device name
- Toraysulfone Dialyzer, Bs-L Series
- Applicant
- Toray Industries (America), Inc.
Bellaire, TX, US - Received
- January 6, 2003
- Decision date
- September 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K042370 | Torayguide GuidewireDQX · Traditional | 12/17/2004SE |
| 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 |
| K884339 | Toray Filtryzer DialyzersFJI · Traditional | 03/17/1989SE |
| 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 Toraysulfone Dialyzer, Bs-L Series cleared by the FDA?
Toraysulfone Dialyzer, Bs-L Series (K030050) received a 510(k) decision of Substantially Equivalent on September 29, 2003, 266 days after the submission was received.
What is the product code of K030050?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.