Edwards Balloon Catheter— 510(k) K153069
Substantially EquivalentEdwards Lifesciences
FDA 510(k) clearance K153069 for Edwards Balloon Catheter, Substantially Equivalent on 2016-01-07. Applicant: Edwards Lifesciences.
Clearance details
- Applicant
- Edwards Lifesciences
- Product code
- Code OMZ
- 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.