Cobe Centrysystem 600 HG Hemodialyzers
FDA 510(k) K960474 · Cobe Renal Care, Inc.
510(k) numberK960474
Submission
- Device name
- Cobe Centrysystem 600 HG Hemodialyzers
- Applicant
- Cobe Renal Care, Inc.
Lakewood, CO, US - Received
- February 2, 1996
- Decision date
- August 14, 1996
- 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
Other 510(k)s with product code KDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 07/24/2026SE |
| K252377 | NxStage System One with NxViewKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/15/2026SE |
| 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 |
|---|---|---|
| K955497 | Gambro FH 22H Fiber Hemofltr/Prisma FH 22H Blood Tubing/Hemofltr SetKDL · Traditional | 09/25/1997SE |
| K955592 | Cobe Centrysystem 14 Pes HemodialyzersKDI · Traditional | 04/30/1997SE |
| K955487 | Gambro Polyflux 14, 17, & 21 HemodialyzersKDI · Traditional | 04/18/1997SE |
| K946279 | Prisma CFM (Continuous Fluid Management System)KDI · Traditional | 02/10/1997SE |
| K954003 | Cobe Hemodynamic Recirculation MonitorMQS · Traditional | 02/06/1997SE |
| K944436 | Cobe Centrysystem CS 200 DialyzerFJI · Traditional | 01/29/1996SE |
| K951311 | Gambro HC 14R HemoconcentratorKDI · Traditional | 01/11/1996SE |
| K952342 | Gambro Lundia 94-700 & Sigma 800 HemodialyzersKDI · Traditional | 09/15/1995SE |
| K945747 | Gambro Lundia 94-600 DialyzerKDI · Traditional | 09/08/1995SE |
| K945746 | Gambro Lundia 94-500 DialyzerFJI · Traditional | 09/08/1995SE |
Questions and answers
When was Cobe Centrysystem 600 HG Hemodialyzers cleared by the FDA?
Cobe Centrysystem 600 HG Hemodialyzers (K960474) received a 510(k) decision of Substantially Equivalent on August 14, 1996, 194 days after the submission was received.
What is the product code of K960474?
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.