Fresenius Polysulfone Hemodialyzers, Both Low and High Flux
FDA 510(k) K970700 · Fresenius USA, Inc.
510(k) numberK970700
Submission
- Device name
- Fresenius Polysulfone Hemodialyzers, Both Low and High Flux
- Applicant
- Fresenius USA, Inc.
Walnut Creek, CA, US - Received
- February 25, 1997
- Decision date
- September 15, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K970650 | Asahi Am-R Series DialyzersMSE · Traditional | Asahi Medical Co., Ltd. | 09/30/1997SE |
More from Asahi Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K992275 | Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol…KDI · Special | 08/04/1999SE |
| K974584 | Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSKDI · Traditional | 05/14/1998SE |
| K973378 | C.A.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model…CAC · Traditional | 11/03/1997SE |
| K961465 | 2008H on Line Clearance MonitorKDI · Traditional | 07/03/1997SE |
| K961706 | P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell SeparatorLKN · Traditional | 07/31/1996SE |
| K955762 | Packpd Peritoneal Dialysis Urea Kinetic Modeling Software ProgramKPF · Traditional | 07/31/1996SE |
| K941460 | Fresenius Blood Temperature MonitorMQS · Traditional | 07/03/1996SE |
| K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFKP · Traditional | 06/13/1996SE |
| K944767 | Dialysis Machine with Dialysate UltrafilterFIP · Traditional | 11/29/1995SE |
| K930181 | Biopure Dialysate Concentrate Mix Syst/ConcentrateFKP · Traditional | 11/29/1995SE |
Questions and answers
When was Fresenius Polysulfone Hemodialyzers, Both Low and High Flux cleared by the FDA?
Fresenius Polysulfone Hemodialyzers, Both Low and High Flux (K970700) received a 510(k) decision of Substantially Equivalent on September 15, 1998, 567 days after the submission was received.
What is the product code of K970700?
The FDA product code is MSE – Hemodialyzer, Re-Use, Low Flux, a Class II (moderate risk) device regulated under 21 CFR 876.5820.