LBW — Set, Dialysis, Single Needle (Co-Axial Flow) Class II
FDA product code LBW covers "Set, Dialysis, Single Needle (Co-Axial Flow)", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LBW
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K904433 | Akcess Medical Products | DUAL LUMEN NEEDLES | Nov 23, 1990 |
| K864629 | Quinton | MODIFIED DUAL LUMEN NEEDLE | Dec 16, 1986 |
| K860515 | Quinton | DUAL LUMEN NEEDLE (PRODUCT CHANGE) | Mar 4, 1986 |
| K820859 | Terumo Medical | COAXIAL DUAL FLOW CATHETER | Apr 16, 1982 |
| K801968 | Medical Components | HEMOCATH I KIDNEY DIALYSIS CATHETER | Sep 26, 1980 |