NYU
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Hemodialysis, Implanted, Coated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant · Life-sustaining
- FDA definition
- Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
- Adverse events (MAUDE)
- 2009: 10 · 2012: 11 · 2022: 16
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 |
|---|---|---|
| PALINDROME H, SI, HSI CHRONIC CATHETER (K112477) | Covidien | 2011-09-28 |
| PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING (K060509) | Tyco Healthcare Group | 2006-06-23 |
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Every clearance here is in the API, with alerts when new ones post.