POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
FDA 510(k) clearance K043342 · decided 2005-05-27
Clearance details
- K-number
- K043342
- Device name
- POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
- Applicant
- Gambro Renal Products
- Decision
- Substantially Equivalent
- Date received
- 2004-12-06
- Decision date
- 2005-05-27
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- FJI
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, 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 |
|---|---|---|
| Hemoflow F3 and F4 Dialyzers (K190459) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-08-23 |
| NIPRO PUREFLUX-L HEMODIALYZER (K122952) | Nipro Medical Corporation | 2013-12-04 |
| DISPOSABLE STORAGE CAP (K010366) | Molded Products, Inc. | 2001-11-28 |
| ULTRACONCENTRATOR SYSTEM (K011148) | Interpore Cross Intl. | 2001-06-13 |
| FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (K002761) | Fresenius Medical Care North America | 2000-12-04 |
| IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (K991908) | Idemsa | 2000-04-17 |
| A-15 HEMODIALYZER (K992594) | Althin Medical AB | 1999-09-24 |
| A-18 HEMODIALYZER (K992565) | Althin Medical AB | 1999-09-23 |
| ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (K991512) | Asahi Medical Co., Ltd. | 1999-07-29 |
| DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (K990159) | Dynamic Technology Corp. | 1999-04-19 |
| CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER (K982337) | Haidylena Medical Egypt | 1998-12-29 |
| ULTRACON ULTRAFILTRATOR (K981253) | Interpore Intl. | 1998-12-11 |
Recalls involving this device
No recalls on record reference this clearance.