LBWClass II
Set, Dialysis, Single Needle (Co-Axial Flow)
21 CFR 876.5540 / Gastroenterology, Urology
LBW is the FDA product code for Set, Dialysis, Single Needle (Co-Axial Flow), a class II device type, regulated under 21 CFR 876.5540. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- LBW
- Device name
- Set, Dialysis, Single Needle (Co-Axial Flow)
- Regulation
- 21 CFR 876.5540
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code LBW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1982 | 1 |
| 1986 | 2 |
| 1990 | 1 |
Applicants with the most clearances
Product code LBW| Applicant | Clearances |
|---|---|
| Quinton, Inc. | 2 |
| Akcess Medical Products, Inc. | 1 |
| Medical Components, Inc. | 1 |
| Terumo Medical Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code LBW.
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