Edwards eSheath+ introducer set— 510(k) K254279
Substantially EquivalentEdwards Lifesciences
FDA 510(k) clearance K254279 for Edwards eSheath+ introducer set, Substantially Equivalent on 2026-04-17. Applicant: Edwards Lifesciences. Device class: 2.
Summary
Edwards Lifesciences' Edwards eSheath+ introducer set is filed under product code DYB (Introducer, Catheter).
Class II, 21 CFR 870.1340. It came in as a Traditional 510(k), and Cardiovascular is both the classification panel and the review panel.
Edwards Lifesciences filed from Irvine, California. Review took 108 calendar days (December 30, 2025 to April 17, 2026).
Clearance details
- Applicant
- Edwards Lifesciences
- Product code
- Product code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DYB
view allMore clearances from Edwards Lifesciences
view all- K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (4 models)
- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
- K253034 — HemoSphere Stream Module
- K252364 — Edwards eSheath Optima introducer set
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.