# Edwards Lifesiences, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 2 (2020–2022): 2 510(k) clearances
- Product codes: DYG (1), DQK (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Edwards Lifesciences, LLC: 5 (https://510kreport.com/company/edwards-lifesciences)
- Cas Medical Systems, Inc.: 1 (https://510kreport.com/company/cas-medical-systems)

## Firms that cite its devices most
- Edwards Lifesciences, LLC: 6 (https://510kreport.com/company/edwards-lifesciences)
- Edwards Lfesciences: 1 (https://510kreport.com/company/edwards-lfesciences)

## Its most-cited devices
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (2020), cited by 6
- K222117: Swang-Ganz IQ pulmonary artery catheter (2022), cited by 1

## Recent decisions
- K222117: Swang-Ganz IQ pulmonary artery catheter (Dec 9, 2022)
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (Oct 1, 2020)

Source page: https://510kreport.com/company/edwards-lifesiences