FDA Product Code
FDA Product Code MSE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001685 | PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 | Baxter Healthcare Corp | 2000-11-15 | Traditional | PDF ↗ |
| K983720 | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- | Asahi Medical Co., Ltd. | 1999-05-17 | Traditional | PDF ↗ |
| K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | Fresenius USA, Inc. | 1998-09-15 | Traditional | PDF ↗ |
| K974090 | 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS | Fresenius Medical Care North America | 1998-08-27 | Traditional | PDF ↗ |
| K970654 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) | Baxter Healthcare Corp | 1997-11-12 | Traditional | PDF ↗ |
| K970661 | CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) | Baxter Healthcare Corp | 1997-11-12 | Traditional | PDF ↗ |
| K970650 | ASAHI AM-R SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1997-09-30 | Traditional | PDF ↗ |
Product code MSE · Class II · Gastroenterology, Urology. Data: openFDA.