# NYU: Catheter, Hemodialysis, Implanted, Coated

- Device class: 2; regulation: 21 CFR 876.5540; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 1
- 2011: 1

## Most-cited predicates
- K060509: Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating (2006), cited by 2
- K112477: Palindrome H, SI, Hsi Chronic Catheter (2011), cited by 1

Source page: https://510kreport.com/product-code/NYU
Data by year (CSV): https://510kreport.com/product-code/NYU.csv