FJT
5 FDA 510(k) clearances · Product code
15 daysmedian time to decision
62 days90th percentile
5clearances measured
FDA profile
- Official device name
- Intracatheter, Dialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1993: 2 · 1994: 1 · 1999: 1 · 2003: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MODIFICATION'S TO TORAY'S B-2 SERIES (K863297) | National Medical Care, Medical Products Div., Inc. | 1986-09-25 |
| CATHETER, FEMORAL VEIN, SF 6 (K772148) | Sorensen Research | 1977-11-29 |
| CATHETER, VEIN, FEMORAL, SF 10 (K772146) | Sorensen Research | 1977-11-29 |
| DNC 151 VINCA-FLO (K770047) | Sorensen Research | 1977-01-14 |
| TRIEX-1 HOLLOW FIBER DIALYZER (K760781) | Extracorporeal Medical Specialities, Inc. | 1976-12-06 |
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Every clearance here is in the API, with alerts when new ones post.