Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing Set
FDA 510(k) K001156 · Gambro Renal Products
510(k) numberK001156
Submission
- Device name
- Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing Set
- Applicant
- Gambro Renal Products
Lakewood, CO, US - Received
- April 10, 2000
- Decision date
- July 7, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| 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 |
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| K133807 | Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitFLD · Traditional | 03/26/2014SE |
| K131516 | Prismaflex System 7.10KDI · Traditional | 01/03/2014SE |
| K130039 | Revaclear 300 Dialyzer, Revaclear 400 DialyzerKDI · Traditional | 05/02/2013SE |
| K113313 | Molecular Adsorbent Recirculating(Mars)FLD · Traditional | 12/14/2012SE |
| K120333 | Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyKPO · Traditional | 05/25/2012SE |
| K110823 | PrismaflexKDI · Traditional | 06/17/2011SE |
| K103832 | Phoenix Hemodialysis Delivery SystemKDI · Traditional | 05/20/2011SE |
| K100451 | Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…MPB · Traditional | 12/21/2010SE |
| K100364 | Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520FJK · Traditional | 11/03/2010SE |
| K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 HFIP · Traditional | 07/29/2010SE |
Questions and answers
When was Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing Set cleared by the FDA?
Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing Set (K001156) received a 510(k) decision of Substantially Equivalent on July 7, 2000, 88 days after the submission was received.
What is the product code of K001156?
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.