Xenium XPH, Models 110, 130, 150, 170, 190 and 210
FDA 510(k) K083778 · Baxter Healthcare Corporation
510(k) numberK083778
Submission
- Device name
- Xenium XPH, Models 110, 130, 150, 170, 190 and 210
- Applicant
- Baxter Healthcare Corporation
Mcgaw Park, IL, US - Received
- December 19, 2008
- Decision date
- February 20, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
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Questions and answers
When was Xenium XPH, Models 110, 130, 150, 170, 190 and 210 cleared by the FDA?
Xenium XPH, Models 110, 130, 150, 170, 190 and 210 (K083778) received a 510(k) decision of Substantially Equivalent on February 20, 2009, 63 days after the submission was received.
What is the product code of K083778?
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.