K233619
- 510(k) number
- K233619
- Device name
- Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
- Applicant
- Edwards Lifesciences CA · US
- Product code
- DXE — Catheter, Embolectomy
- Decision date
- 2024-05-20
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233619.pdf
Official FDA record: K233619
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.