FJT — Intracatheter, Dialysis Class II
FDA product code FJT covers "Intracatheter, Dialysis", a Class II medical device regulated under 21 CFR 876.5820. 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
- FJT
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K863297 | national medical care, medical products div | MODIFICATION'S TO TORAY'S B-2 SERIES | September 25, 1986 |
| K772146 | sorensen research | CATHETER, VEIN, FEMORAL, SF 10 | November 29, 1977 |
| K772148 | sorensen research | CATHETER, FEMORAL VEIN, SF 6 | November 29, 1977 |
| K770047 | sorensen research | DNC 151 VINCA-FLO | January 14, 1977 |
| K760781 | extracorporeal medical specialities | TRIEX-1 HOLLOW FIBER DIALYZER | December 6, 1976 |