Product Code: LBW
FDA class 2
21 CFR 876.5540
Set, Dialysis, Single Needle (Co-Axial Flow)
Gastroenterology, Urology
A single-needle co-axial flow dialysis set is a dialysis access system that uses a single vascular needle and co-axial flow design to alternately withdraw and return blood during hemodialysis when two-needle access is not feasible. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and falls within the Gastroenterology, Urology specialty under 21 CFR 876.5540. The product code is LBW. This device is flagged as an implant, reflecting its intravascular contact during use.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
10
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Basic Information
- Product Code
- LBW
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904433 | DUAL LUMEN NEEDLES | Nov 23, 1990 | Substantially Equivalent | Akcess Medical Products, Inc. |
| K864629 | MODIFIED DUAL LUMEN NEEDLE | Dec 16, 1986 | Substantially Equivalent | Quinton, Inc. |
| K860515 | DUAL LUMEN NEEDLE (PRODUCT CHANGE) | Mar 04, 1986 | Substantially Equivalent | Quinton, Inc. |
| K820859 | COAXIAL DUAL FLOW CATHETER | Apr 16, 1982 | Substantially Equivalent | Terumo Medical Corp. |
| K801968 | HEMOCATH I KIDNEY DIALYSIS CATHETER | Sep 26, 1980 | Substantially Equivalent | Medical Components, Inc. |