K233820
- 510(k) number
- K233820
- Device name
- Fogarty Arterial Embolectomy Catheter with Gate Valve
- Applicant
- Edwards Lifesciences CA · US
- Product code
- DXE — Catheter, Embolectomy
- Decision date
- 2024-05-22
- Date received
- 2023-12-01
- 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: K233820.pdf
Official FDA record: K233820
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.