# PZS: Dual Lumen Ecmo Cannula

- Device class: 2; regulation: 21 CFR 870.4100; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 108 days (middle half 80–137)
- 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)
- 2017: 1
- 2018: 1
- 2021: 1
- 2023: 1

## Most-cited predicates
- K180151: MC3 Jugular Dual Lumen Catheter (2018), cited by 2
- K171610: MC3 QuickFlow Dual Lumen Catheter (2017), cited by 1

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