Asahi Am-R Series Dialyzers
FDA 510(k) K970650 · Asahi Medical Co., Ltd.
510(k) numberK970650
Submission
- Device name
- Asahi Am-R Series Dialyzers
- Applicant
- Asahi Medical Co., Ltd.
Rockville, MD, US - Received
- February 20, 1997
- Decision date
- September 30, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSE – Hemodialyzer, Re-Use, Low Flux
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code MSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001685 | PSN Hemodialyzer, Model PSN 130, 150, 170, 210MSE · Traditional | Baxter Healthcare Corp | 11/15/2000SE |
| K983720 | Asahi Am-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-BIO-50,AM-BIO-65…MSE · Traditional | Asahi Medical Co., Ltd. | 05/17/1999SE |
| K970700 | Fresenius Polysulfone Hemodialyzers, Both Low and High FluxMSE · Traditional | Fresenius USA, Inc. | 09/15/1998SE |
| K974090 | 95 C/1.5 Citric Acid Heat Processing of Polysulfone DialyzersMSE · Traditional | Fresenius Medical Care North America | 08/27/1998SE |
| K970661 | Ca Cellulose Acetate Hollow Fiber Dialyzer (CA-90)MSE · Traditional | Baxter Healthcare Corp | 11/12/1997SE |
| K970654 | Cahp High Performance Cellulose Diacetate (Capillary, Hollow Fiber)MSE · Traditional | Baxter Healthcare Corp | 11/12/1997SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…KDI · Special | 07/23/2004SE |
| K013418 | Am-Bio Extended Range Series Dialyzer, Models Wet and DryKDI · Traditional | 07/09/2002SE |
| 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 |
| 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 Asahi Am-R Series Dialyzers cleared by the FDA?
Asahi Am-R Series Dialyzers (K970650) received a 510(k) decision of Substantially Equivalent on September 30, 1997, 222 days after the submission was received.
What is the product code of K970650?
The FDA product code is MSE – Hemodialyzer, Re-Use, Low Flux, a Class II (moderate risk) device regulated under 21 CFR 876.5820.