PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)— 510(k) K172423
Substantially EquivalentEdwards Lifescience, LLC
FDA 510(k) clearance K172423 for PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter), Substantially Equivalent on 2018-02-20. Applicant: Edwards Lifescience, LLC.
Clearance details
- Applicant
- Edwards Lifescience, LLC
- Product code
- Code DQE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.