# DYG: Catheter, Flow Directed

- Device class: 2; regulation: 21 CFR 870.1240; FDA's rule: 510(k) required
- FDA decisions: 99
- 510(k) review time 2021–2025: median 144 days (middle half 143–188)
- Recalls: 36 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2001: 1
- 2002: 3
- 2004: 2
- 2008: 1
- 2011: 1
- 2016: 1
- 2020: 1
- 2022: 1
- 2023: 1
- 2024: 3

## Most-cited predicates
- K160084: Swan Ganz Catheters (2016), cited by 6
- K934742: Swan-Ganz Continuous Cardiac Output/Oximetry/Venous Port (1994), cited by 3
- K001063: Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7, S146F7, S146HF7 (2000), cited by 2
- K810352: Swan-Ganz Flow-Directed Thermodilution (1981), cited by 2
- K961999: Schneider Guider Softip Guiding Catheters (1996), cited by 2
- K810124: Swan-Ganz Vip Thermodilution Catheter (1981), cited by 2
- K231248: Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (2023), cited by 2
- K242451: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (2024), cited by 2
- K822806: Balloon Wedge Pressure, Angiographic (1982), cited by 2
- K925444: Cardiac Output Pulmonary Artery Catheter & Monitor (1993), cited by 1

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