Am-Bio Extended Range Series Dialyzer, Models Wet and Dry
FDA 510(k) K013418 · Asahi Medical Co., Ltd.
510(k) numberK013418
Submission
- Device name
- Am-Bio Extended Range Series Dialyzer, Models Wet and Dry
- Applicant
- Asahi Medical Co., Ltd.
Rockville, MD, US - Received
- October 15, 2001
- Decision date
- July 9, 2002
- 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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| 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 |
|---|---|---|
| K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…KDI · Special | 07/23/2004SE |
| K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)KDI · Traditional | 08/16/2000SE |
| K991512 | Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional | 07/29/1999SE |
| K983720 | Asahi Am-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-BIO-50,AM-BIO-65…MSE · Traditional | 05/17/1999SE |
| K970650 | Asahi Am-R Series DialyzersMSE · Traditional | 09/30/1997SE |
| K914020 | Modified Asahi Pan-Series HemofiltersKDI · Traditional | 03/20/1992SE |
| K901887 | Modified Sepacell R-Series Blood FiltersCAK · Traditional | 08/08/1990SE |
| K896976 | Modified Sepacell R-500 and R-500A Blood FiltersCAK · Traditional | 01/24/1990SE |
| K896664 | Modified Sepacell Pl-Series Leukocyte Removal FiltCAK · Traditional | 01/24/1990SE |
| K892375 | Modified Am-Series DialyzersFJI · Traditional | 05/18/1989SE |
Questions and answers
When was Am-Bio Extended Range Series Dialyzer, Models Wet and Dry cleared by the FDA?
Am-Bio Extended Range Series Dialyzer, Models Wet and Dry (K013418) received a 510(k) decision of Substantially Equivalent on July 9, 2002, 267 days after the submission was received.
What is the product code of K013418?
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.