Phoenix Hemodialysis Delivery System, Version 3.35
FDA 510(k) K070643 · Gambro, Inc.
510(k) numberK070643
Submission
- Device name
- Phoenix Hemodialysis Delivery System, Version 3.35
- Applicant
- Gambro, Inc.
Lakewood, CO, US - Received
- March 8, 2007
- Decision date
- November 2, 2007
- 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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| K083158 | Exalis, Software Version 1.15KDI · Traditional | 06/05/2009SE |
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| K032431 | Prisma M60/M100 SetsKDI · Special | 09/15/2003SE |
| K896758 | Gambro Bicarbonate Monitor BCM 10-3FKP · Traditional | 09/28/1990SE |
| K896757 | Gambro AK-10 Dialysis System for High FlowsFKP · Traditional | 08/30/1990SE |
| K902481 | Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional | 07/27/1990SE |
| K900918 | Gambro Lundia IC-6H Parallel Plate DialyzerKDI · Traditional | 07/16/1990SE |
| K892523 | Gambro Alwall GFS 11,12,PLUS 12 Hollow Fiber DialyFJI · Traditional | 05/11/1989SE |
| K890112 | Engstrom Eliza + CO2 AnalyzerCCK · Traditional | 03/15/1989SE |
| K890111 | Gambro Alwall Gfe 8 & 9 Hollow Fiber DialyzerFJI · Traditional | 02/08/1989SE |
Questions and answers
When was Phoenix Hemodialysis Delivery System, Version 3.35 cleared by the FDA?
Phoenix Hemodialysis Delivery System, Version 3.35 (K070643) received a 510(k) decision of Substantially Equivalent on November 2, 2007, 239 days after the submission was received.
What is the product code of K070643?
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.