K244046
- 510(k) number
- K244046
- Device name
- Edwards eSheath Optima introducer set
- Applicant
- Edwards Lifesciences CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-03-27
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K244046.pdf
Official FDA record: K244046
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.