FDA product code FJT: Intracatheter, Dialysis
FJT is the FDA product code for intracatheter, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FJT, from 3 different applicants. The average 510(k) review took 25 days (median 15).
Classification
| Field | Value |
|---|---|
| Device name | Intracatheter, Dialysis |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FJT clearance
Top FJT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sorensen Research | 3 | 1977-11-29 |
| National Medical Care, Medical Products Div., Inc. | 1 | 1986-09-25 |
| Extracorporeal Medical Specialities, Inc. | 1 | 1976-12-06 |
Most recent FJT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863297 | National Medical Care, Medical Products Div., Inc. | MODIFICATION'S TO TORAY'S B-2 SERIES | 1986-09-25 | 31 |
| K772146 | Sorensen Research | CATHETER, VEIN, FEMORAL, SF 10 | 1977-11-29 | 15 |
| K772148 | Sorensen Research | CATHETER, FEMORAL VEIN, SF 6 | 1977-11-29 | 15 |
| K770047 | Sorensen Research | DNC 151 VINCA-FLO | 1977-01-14 | 4 |
| K760781 | Extracorporeal Medical Specialities, Inc. | TRIEX-1 HOLLOW FIBER DIALYZER | 1976-12-06 | 62 |
Recalls for FJT devices
openFDA lists no recalls for product code FJT.
Frequently asked questions
What is FDA product code FJT?
FJT is the FDA product code for intracatheter, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJT?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJT?
Across 5 cleared submissions the average was 25 days from receipt to decision (median 15).
Which companies have the most FJT clearances?
Sorensen Research (3); National Medical Care, Medical Products Div., Inc. (1); Extracorporeal Medical Specialities, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FJT
- Run a recall and safety report across every FJT manufacturer
- Watch product code FJT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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