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. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences
- Product code
- Code OMZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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