FJTClass II
Intracatheter, Dialysis
21 CFR 876.5820 / Gastroenterology, Urology
FJT is the FDA product code for Intracatheter, Dialysis, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FJT
- Device name
- Intracatheter, Dialysis
- Regulation
- 21 CFR 876.5820
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code FJT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 3 |
| 1986 | 1 |
Applicants with the most clearances
Product code FJT| Applicant | Clearances |
|---|---|
| Sorensen Research | 3 |
| Extracorporeal Medical Specialities, Inc. | 1 |
| National Medical Care, Medical Products Div., Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code FJT.
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