PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA— 510(k) K983791
Substantially EquivalentEdwards Lifesciences Research Medical
FDA 510(k) clearance K983791 for PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA, Substantially Equivalent on 1999-06-11. Applicant: Edwards Lifesciences Research Medical.
Clearance details
- Applicant
- Edwards Lifesciences Research Medical
- Product code
- Code DWF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Midvale, UT, US
Adverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
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.