Gambro Polyflux II Hemodialyzerialyzer Hemodiafilter
FDA 510(k) K933818 · C.G.H. Medical, Inc.
510(k) numberK933818
Submission
- Device name
- Gambro Polyflux II Hemodialyzerialyzer Hemodiafilter
- Applicant
- C.G.H. Medical, Inc.
Lakewood, CO, US - Received
- August 4, 1993
- Decision date
- January 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/10/2026SE |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | Outset Medical, Inc. | 01/26/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 12/18/2025SE |
| K243920 | Purema H Hemoconcentrator - PediatricKDI · Traditional | Medica USA, Inc. | 09/19/2025SE |
| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K941708 | Cobe Centrysystem CS500 DialyzerFJI · Traditional | 05/12/1995SE |
| 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 Gambro Polyflux II Hemodialyzerialyzer Hemodiafilter cleared by the FDA?
Gambro Polyflux II Hemodialyzerialyzer Hemodiafilter (K933818) received a 510(k) decision of Substantially Equivalent on January 25, 1995, 539 days after the submission was received.
What is the product code of K933818?
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.