K241330
- 510(k) number
- K241330
- Device name
- Fogarty Fortis Arterial Embolectomy Catheter
- Applicant
- Edwards Lifesciences CA · US
- Product code
- DXE — Catheter, Embolectomy
- Decision date
- 2024-07-02
- Date received
- 2024-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241330.pdf
Official FDA record: K241330
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.