# PCB: External Cerebrospinal Fluid (Csf) Diversion

- Device class: 2; regulation: 21 CFR 882.5560; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 105 days (middle half 105–105)
- 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)
- 2014: 1
- 2024: 1

## Most-cited predicates
- DEN120017: Medtronic DUET External Drainage and Monitoring System (2014), cited by 1

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