# NLG: Catheter, Intracardiac Mapping, High-Density, Reprocessed

- Device class: 2; regulation: 21 CFR 870.1220; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 140 days (middle half 125–155)
- Recalls: 0 (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)
- 2019: 1
- 2021: 2

## Most-cited predicates

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