# Edwards Lifescience, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 1 (2018–2018): 1 510(k) clearance
- Product codes: DQE (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (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: 2 (https://510kreport.com/company/edwards-lifesciences)

## Recent decisions
- K172423: PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) (Feb 20, 2018)

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