CARPENTIER-EDWARDS FLEX. ANNULOPLASTY— 510(k) K792441
Substantially Equivalent - Subject to Tracking & PMSEdwards Laboratories
FDA 510(k) clearance K792441 for CARPENTIER-EDWARDS FLEX. ANNULOPLASTY, Substantially Equivalent - Subject to Tracking & PMS on 1980-03-17. Applicant: Edwards Laboratories.
Clearance details
- Applicant
- Edwards Laboratories
- Product code
- Code KRH
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking & PMS
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code KRH
product code KRH- Death
- 45
- Injury
- 2,235
- Total
- 2,280
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.