Cobe Centrysystem CS500 Dialyzer
FDA 510(k) K941708 · C.G.H. Medical, Inc.
510(k) numberK941708
Submission
- Device name
- Cobe Centrysystem CS500 Dialyzer
- Applicant
- C.G.H. Medical, Inc.
Lakewood, CO, US - Received
- April 6, 1994
- Decision date
- May 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K933818 | Gambro Polyflux II Hemodialyzerialyzer HemodiafilterKDI · Traditional | 01/25/1995SE |
| K925522 | Centrysystem 3 with Charts/Bp OptionKOC · Traditional | 09/30/1994SE |
| K920757 | Filtral HemodialyzersKDI · Traditional | 08/05/1994SE |
| K931720 | Lundia Alpha 700 HemodialyzerKDI · Traditional | 07/07/1994SE |
| K924437 | Hemospal Kit B22 / Multiflow 60 KitKDI · Traditional | 06/27/1994SE |
| K940601 | Gambro Bicart 720GKPO · Traditional | 03/22/1994SE |
| K915154 | Gambro Engstrom Y Filter Pkg. Alone W/ Var.ModelsCAN · Traditional | 05/27/1992SE |
| K914271 | Gambro Engstrom Y-Filter with Edith Flex (1500F)CAN · Traditional | 04/13/1992SE |
| K915504 | Gambro Lundia Alpha HemodialyzersFJG · Traditional | 03/06/1992SE |
| K911603 | Hemospal Kit B22KDI · Traditional | 08/07/1991SE |
Questions and answers
When was Cobe Centrysystem CS500 Dialyzer cleared by the FDA?
Cobe Centrysystem CS500 Dialyzer (K941708) received a 510(k) decision of Substantially Equivalent on May 12, 1995, 401 days after the submission was received.
What is the product code of K941708?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.