# NDQ: System, Catheter Or Guidewire, Steerable (Magnetic)

- Device class: 2; regulation: 21 CFR 870.1290; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 2005: 1
- 2006: 1

## Most-cited predicates
- K060967: Niobe Magnetic Navigation System W/Navigant Workstation (2006), cited by 4

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