Product Code: FLC
FDA class 2
21 CFR 876.5820
Station, Dialysis Control, Negative Pressure Type
Gastroenterology, Urology
The Negative-Pressure Dialysis Control Station is a device that monitors and controls transmembrane pressure in the dialysis circuit by applying negative pressure, used to regulate ultrafiltration during hemodialysis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLC, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
14
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Basic Information
- Product Code
- FLC
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K910656 | WILSON-COOK DISPOSABLE BIOPSY FORCEPS | Apr 25, 1991 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
| K855001 | FRESENIUS HEMODIALYSIS MACHINE A1008 BSM | Jan 21, 1986 | Substantially Equivalent | Seratronics, Inc. |
| K791164 | NEGATOVE PRESSURE CONVERTOR | Oct 04, 1979 | Substantially Equivalent | Medicorp, Inc. |
| K760725 | COIL MACHINE ADAPTER | Oct 27, 1976 | Substantially Equivalent | Gambro, Inc. |