Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters— 510(k) K233619
Substantially EquivalentEdwards Lifesciences
FDA 510(k) clearance K233619 for Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters, Substantially Equivalent on 2024-05-20. Applicant: Edwards Lifesciences.
Clearance details
- Applicant
- Edwards Lifesciences
- Product code
- Code DXE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code DXE
product code DXE- Death
- 27
- Injury
- 258
- Malfunction
- 2,266
- Total
- 2,551
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.