510(k) K970648
- Device
- PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
- Applicant
- RENAL SYSTEMS, INC.
- 510(k) number
- K970648
- Product code
- MSF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-01-05
- Date received
- 1997-02-20
- Regulation
- 876.5860
- Classification name
- Hemodialyzer, Re-use, High Flux
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN M LUEDERS
- Address
- 14605 28th Ave. N. Minneapolis MN US 55447 55447
FDA Registration Numbers#
- 1721676
- 9611369
- 8030639
- 3038195011
- 3002807408
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MSF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023615 | GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR | Gambro Renal Products | 2003-05-06 |
| K994390 | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER | Gambro Healthcare | 2000-10-26 |
| K970679 | ALTRA FLUX 200 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 |
| K970681 | ALTRA NOVA 200 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 |
| K970653 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) | Baxter Healthcare Corp | 1998-03-11 |
| K970662 | CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) | Baxter Healthcare Corp | 1998-03-11 |
| K970663 | CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) | Baxter Healthcare Corp | 1998-01-11 |
Legacy Summary#
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FDA Review#
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