GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
FDA 510(k) clearance K994390 · decided 2000-10-26
Clearance details
- K-number
- K994390
- Device name
- GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
- Applicant
- Gambro Healthcare
- Decision
- Substantially Equivalent
- Date received
- 1999-12-28
- Decision date
- 2000-10-26
- Days to decision
- 303 days
- Clearance type
- Traditional
- Product code
- MSF
- Device class
- 2
- Regulation number
- 876.5860
- 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 |
|---|---|---|
| GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR (K023615) | Gambro Renal Products | 2003-05-06 |
| ALTRA NOVA 200 HEMODIALYZER (K970681) | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 |
| ALTRA FLUX 200 HEMODIALYZER (K970679) | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 |
| CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (K970653) | Baxter Healthcare Corp | 1998-03-11 |
| CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) (K970662) | Baxter Healthcare Corp | 1998-03-11 |
| CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) (K970663) | Baxter Healthcare Corp | 1998-01-11 |
| PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (K970648) | Renal Systems, Inc. | 1998-01-05 |
Recalls involving this device
No recalls on record reference this clearance.