FII — System, Dialysate Delivery, Sealed Class II
FDA product code FII covers "System, Dialysate Delivery, Sealed", a Class II medical device regulated under 21 CFR 876.5860. Submissions are reviewed by the Gastroenterology, Urology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FII
- Device Class
- Class II
- Regulation Number
- 876.5860
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K030470 | nxstage medical | NXSTAGE SYSTEM ONE | July 7, 2003 |
| K881270 | gambro | GAMBRO MULTIPURPOSE SYSTEM MPS-10 | August 24, 1988 |
| K872364 | travenol laboratories | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | October 13, 1987 |
| K862716 | gambro | HEMOFILTRATION SYSTEM 10 | September 9, 1986 |
| K822386 | hospal medical | COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA | October 6, 1982 |