K254279
- 510(k) number
- K254279
- Device name
- Edwards eSheath+ introducer set
- Applicant
- Edwards Lifesciences CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-04-17
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K254279.pdf
Official FDA record: K254279
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.