95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
FDA 510(k) clearance K974090 · decided 1998-08-27
Clearance details
- K-number
- K974090
- Device name
- 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 1997-10-29
- Decision date
- 1998-08-27
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- MSE
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walnut Creek, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 (K001685) | Baxter Healthcare Corp | 2000-11-15 |
| 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- (K983720) | Asahi Medical Co., Ltd. | 1999-05-17 |
| FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (K970700) | Fresenius USA, Inc. | 1998-09-15 |
| CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) (K970661) | Baxter Healthcare Corp | 1997-11-12 |
| CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (K970654) | Baxter Healthcare Corp | 1997-11-12 |
| ASAHI AM-R SERIES DIALYZERS (K970650) | Asahi Medical Co., Ltd. | 1997-09-30 |
Recalls involving this device
No recalls on record reference this clearance.