95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers
FDA 510(k) K974090 · Fresenius Medical Care North America
510(k) numberK974090
Submission
- Device name
- 95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers
- Applicant
- Fresenius Medical Care North America
Walnut Creek, CA, US - Received
- October 29, 1997
- Decision date
- August 27, 1998
- 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 |
| 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 |
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Questions and answers
When was 95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers cleared by the FDA?
95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers (K974090) received a 510(k) decision of Substantially Equivalent on August 27, 1998, 302 days after the submission was received.
What is the product code of K974090?
The FDA product code is MSE – Hemodialyzer, Re-Use, Low Flux, a Class II (moderate risk) device regulated under 21 CFR 876.5820.