Product Code: FIF
FDA class 2
21 CFR 876.5820
Set, Dialysis, Single Needle With Uni-Directional Pump
Gastroenterology, Urology
The Single Needle Dialysis Set with Uni-Directional Pump is a system that enables hemodialysis using a single vascular access point, with a uni-directional pump alternating blood flow between the patient and the dialyzer. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FIF, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.
510(k)s
6
FEI Numbers
0
Registration Numbers
0
Unique Applicants
6
Years Active
10
Basic Information
- Product Code
- FIF
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✓
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K873279 | 8810 PUMP-PUMP SINGLE NEEDLE DEVICE | Oct 23, 1987 | Substantially Equivalent | CD MEDICAL, INC. |
| K820173 | COBE SINGLE-NEEDLE CONTROLLER #18-756 | Mar 23, 1982 | Substantially Equivalent | COBE LABORATORIES, INC. |
| K802230 | BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP | Dec 22, 1980 | Substantially Equivalent | CARDIO MED SUPPLIES, INC. |
| K801967 | MEDCOMP FEMORAL VEIN CATHETER | Sep 26, 1980 | Substantially Equivalent | MEDICAL COMPONENTS, INC. |
| K792174 | MODEL DM 353 & DM-353-L SINGLE NEEDLE | Nov 16, 1979 | Substantially Equivalent | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
| K772147 | GW 35 GUIDE WIRE | Nov 28, 1977 | Substantially Equivalent | SORENSEN RESEARCH |