Ascendra Balloon Aortic Valvaloplasty Catheter— 510(k) K142199
Substantially EquivalentEdwards Lifesciences
FDA 510(k) clearance K142199 for Ascendra Balloon Aortic Valvaloplasty Catheter, Substantially Equivalent on 2014-10-29. Applicant: Edwards Lifesciences. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences
- Product code
- Code OZT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1255
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code OZT
view allMore clearances from Edwards Lifesciences
view allAdverse events under product code OZT
product code OZT- Death
- 20
- Other
- 2
- Total
- 22
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.