LBW — Set, Dialysis, Single Needle (Co-Axial Flow) Class II
FDA Device Classification
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 | November 23, 1990 |
| K864629 | quinton | MODIFIED DUAL LUMEN NEEDLE | December 16, 1986 |
| K860515 | quinton | DUAL LUMEN NEEDLE (PRODUCT CHANGE) | March 4, 1986 |
| K820859 | terumo medical | COAXIAL DUAL FLOW CATHETER | April 16, 1982 |
| K801968 | medical components | HEMOCATH I KIDNEY DIALYSIS CATHETER | September 26, 1980 |