FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
K Number: K970648
·
Decision Jan 5, 1998
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
35
Review Days
319
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Basic Information
- Device Name
- PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
- K Number
- K970648
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Renal Systems, Inc.
- Date Received
- February 20, 1997
- Decision Date
- January 5, 1998
- Product Code
- MSF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSF | Hemodialyzer, Re-Use, High Flux | FDA class 2 | Gastroenterology, Urology |
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ALTRA NOVA 200 HEMODIALYZER
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CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
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CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
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Other Clearances by Renal Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT | Jun 9, 1987 | Substantially Equivalent |
| K854011 | RENALFO HEMOFILTER CAVHD | Nov 5, 1985 | Substantially Equivalent |
| K844790 | RENAFLO HEMOCONCENTRATOR | May 23, 1985 | Substantially Equivalent |
| K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD | Jan 7, 1985 | Substantially Equivalent |
| K844108 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM | Jan 7, 1985 | Substantially Equivalent |
| K842258 | RENATRON | Jul 6, 1984 | Substantially Equivalent |
| K841543 | CONCENTRATE CONDUCTIVITY METER | May 22, 1984 | Substantially Equivalent |
| K840182 | RENAPAK CONCENTRATE MIXING SYS. | May 2, 1984 | Substantially Equivalent |
| K840437 | HEMASITE ACCESSORIES MODIFICATION | Feb 21, 1984 | Substantially Equivalent |
| K840436 | HEMASITE/RENALOY -VASCULAR ACCESS SHUNT | Feb 21, 1984 | Substantially Equivalent |